Tedan Surgical Innovations, Inc.
Sugar Land, TX, US
TEDAN SURGICAL INNOVATIONS, INC. appears in FDA device records in Sugar Land, TX. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 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 4 510(k) clearances for Tedan Surgical Innovations, Inc. between 2014 and 2026. The busiest year on record is 2014, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | PDQ | Substantially Equivalent | |
| K231691 | Phantom XL Insulated Dilators | GXZ | Substantially Equivalent | |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | GZT | Substantially Equivalent | |
| K140088 | PHANTOM XL INSULATED DILATORS | PDQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005726885 | 3005726885 | TEDAN SURGICAL INNOVATIONS, INC. | 12320 Cardinal Meadow Drive, Sugar Land, TX 77478 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTZCaliper
- FZSCurette, Surgical, General Use
- GFCDriver, Surgical, Pin
- GXZElectrode, Needle
- GEGElevator, Surgical, General & Plastic Surgery
- HTJGauge, Depth
- FXRHolder, Camera, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- PDQNeurosurgical Nerve Locator
- FWZOperating Room Accessories Table Tray
- LXHOrthopedic Manual Surgical Instrument
- HXBProbe
- HTRRasp
- GADRetractor
- FDGRetractor, Fiberoptic
- GZTRetractor, Self-Retaining, For Neurosurgery
- HTXRongeur
- HXXScrewdriver
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2530-2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2529-2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2528-2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2527-2020 | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2526-2020 | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2525-2020 | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-2524-2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | Class II | Terminated | |
| Z-1845-2020 | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for general use intended to be used in various general surgical procedures. They are reusable devices that are connected to the hospital suction system to remove debris and blood from the surgical field. | There was incorrect raw material used in the production of the identified lot. | Class II | Terminated | |
| Z-1506-2020 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. | The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients. | Class II | Terminated | |
| Z-1505-2020 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. | The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients. | Class II | Terminated | |
| Z-1504-2020 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. | The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients. | Class II | Terminated | |
| Z-1503-2020 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. | The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients. | Class II | Terminated | |
| Z-2385-2012 | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine. | This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain