The Orthopaedic Implant Company
Reno, NV, US
THE ORTHOPAEDIC IMPLANT COMPANY appears in FDA device records in Reno, NV. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no 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 15 510(k) clearances for The Orthopaedic Implant Company between 2012 and 2024. The busiest year on record is 2018, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242995 | OIC Small / Mini Fragment Plate System | HRS | Substantially Equivalent | |
| K233531 | OIC FLEX-FIX™ System | HTN | Substantially Equivalent | |
| K223761 | OIC Intramedullary Screw System | HWC | Substantially Equivalent | |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | HRS | Substantially Equivalent | |
| K212601 | DRPx Locking Distal Radius Plate System | HRS | Substantially Equivalent | |
| K202971 | DRPx Locking Distal Radius Plate System | HRS | Substantially Equivalent | |
| K211112 | OIC External Fixation System | KTT | Substantially Equivalent | |
| K183682 | OIC External Fixation System | KTT | Substantially Equivalent | |
| K182736 | OIC Suture Anchor System | MBI | Substantially Equivalent | |
| K181184 | OIC Intramedullary Nail System | HSB | Substantially Equivalent | |
| K171211 | OIC External Fixation System | KTT | Substantially Equivalent | |
| K160222 | OIC Cervical PEEK Spacer | ODP | Substantially Equivalent | |
| K150655 | OIC Intramedullary Nail System | HSB | Substantially Equivalent | |
| K140357 | OIC VARIABLE ANGLE SMALL FRAGMENT LOCKING PLATE SYSTEM | HRS | Substantially Equivalent | |
| K113123 | OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM | KTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008599979 | 3008599979 | THE ORTHOPAEDIC IMPLANT COMPANY | 770 Smithridge Dr Ste 400, Reno, NV 89502 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HTWBit, Drill
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- HRSPlate, Fixation, Bone
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- HTNWasher, Bolt Nut
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain