Tyber Medical
Bethlehem, PA, US
Tyber Medical appears in FDA device records in Bethlehem, PA. FDA records list 31 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Tyber Medical between 2013 and 2026. The busiest year on record is 2023, with 6. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 3 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 6 |
| 2024 | 1 |
| 2025 | 4 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261207 | Exalta Proximal Tibia Plating System | HRS | Substantially Equivalent | |
| K260810 | Anteralign LS coverplate | OVD | Substantially Equivalent | |
| K261060 | Navigated LLIF Impactable Tracker | OLO | Substantially Equivalent | |
| K253042 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | |
| K252901 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | |
| K252742 | Navigated Instruments | OLO | Substantially Equivalent | |
| K251361 | Tyber Medical Distal Radius Plating System | HRS | Substantially Equivalent | |
| K242486 | Tyber Medical Anatomical Plating System | HRS | Substantially Equivalent | |
| K241218 | Tyber Medical Anatomical Plating System | HRS | Substantially Equivalent | |
| K233423 | Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System | HRS | Substantially Equivalent | |
| K233017 | TM Plating System | HRS | Substantially Equivalent | |
| K232652 | Anatomical Plating System (various) | HRS | Substantially Equivalent | |
| K232693 | Tyber Medical Distal Radius Plating System | HRS | Substantially Equivalent | |
| K231339 | Tyber Medical Pin and Wire System (various) | HTY | Substantially Equivalent | |
| K222465 | Tyber Medical Anatomical Plating System | HRS | Substantially Equivalent | |
| K221947 | Tyber Medical Staple Fixation System (various) | JDR | Substantially Equivalent | |
| K203817 | Tyber Medical Anatomical Plating System | HRS | Substantially Equivalent | |
| K193222 | Tyber Medical Anatomical Plating System | HRS | Substantially Equivalent | |
| K192975 | Tyber Medical Trauma Screws | HWC | Substantially Equivalent | |
| K192974 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | |
| K182284 | Tyber Medical PT Interbody Spacer | ODP | Substantially Equivalent | |
| K180590 | Tyber Medical PT Interbody Spacer System | ODP | Substantially Equivalent | |
| K172185 | Tyber Medical PT Interbody Spacer System | ODP | Substantially Equivalent | |
| K170571 | Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw | HWC | Substantially Equivalent | |
| K171327 | Tyber Medical Wedge System | PLF | Substantially Equivalent | |
| K161597 | Tyber Medical BioTy® Nanotopography Trauma Screw | HWC | Substantially Equivalent | |
| K153575 | Tyber Medical Trauma Screw | HWC | Substantially Equivalent | |
| K153180 | Tyber Medical MST Trauma Screw | HWC | Substantially Equivalent | |
| K150394 | Tyber Medical Wedge System | PLF | Substantially Equivalent | |
| K133842 | TYBER MEDICAL TRAUMA SCREW | HWC | Substantially Equivalent | |
| K130573 | TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF | ODP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012966183 | 3012966183 | Tyber Medical | 83 South Commerce Way, Bethlehem, PA 18017 US | 2026 | and 16 more, listed in full below |
| 3017980495 | 3017980495 | Tyber Medical | 89 South Commerce Way, Bethlehem, PA 18017 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HTWBit, Drill
- PLFBone Wedge
- HWWCountersink
- FZSCurette, Surgical, General Use
- GDIDissector, Surgical, General & Plastic Surgery
- HTJGauge, Depth
- FZYHammer, Surgical
- HTZInstrument, Cutting, Orthopedic
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- HWMOsteotome
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- HTRRasp
- HTOReamer
- GADRetractor
- HTXRongeur
- HWCScrew, Fixation, Bone
- LRZScrewdriver, Surgical
- JDRStaple, Fixation, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1132-2026 | Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No | The supplier manufactured anatomical left plates with an incorrect thread orientation. | Class II | Open, Classified | |
| Z-1131-2026 | Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm | The supplier manufactured anatomical left plates with an incorrect thread orientation. | Class II | Open, Classified | |
| Z-1226-2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1225-2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715161 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1224-2025 | A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1223-2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1222-2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1221-2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1220-2025 | A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right Model/Catalog Number: 770715062 Intended for Fixation of fractures of the distal tibia | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1219-2025 | A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1218-2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708122 Product Description: | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1217-2025 | A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1216-2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right. Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770708102 Product Description: | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1215-2025 | A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770708101 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1214-2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1213-2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1212-2025 | A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1211-2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1210-2025 | A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right Model/Catalog Number: 770708042 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified | |
| Z-1209-2025 | A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708041 | Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain