Instratek, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Instratek, Inc.” (first 1992, latest 2014), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 90 |
| 2013 | 1 | 52 |
| 2014 | 1 | 83 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 3 | 3 |
| HTN | Washer, Bolt Nut | 3 | 3 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Instratek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133523 | STAPIX SUPERELASTIC IMPLANT BONE STAPLES | JDR | 2014-02-06 | 83 |
| K131620 | JONES-FX FRACTURE SYSTEM | HWC | 2013-07-25 | 52 |
| K120493 | MINI CANNULATED HEADED AND HEADLESS SCREW SET | HWC | 2012-05-17 | 90 |
| K111032 | CMC CABLE FIX | HTN | 2011-08-31 | 140 |
| K091763 | MICHELANGELO BUNION SYSTEM - MABS, MODEL: MA6000 | HTN | 2009-08-14 | 59 |
| K082384 | HAV-LOK BUNION CORRECTION SYSTEM | HTN | 2008-12-08 | 111 |
| K080280 | SUB-TALAR LOK, MODEL 7-11 MM | HWC | 2008-03-14 | 39 |
| K940230 | ENDOSCOPIC MORTONS NEUROMA INSTRUMENTS | HRX | 1994-12-12 | 332 |
| K925083 | ENDOTRAK SYSTEM | HRX | 1993-04-27 | 202 |
| K922391 | ENDOSCOPIC CARPAL TUNNEL INSTRUMENTS | HRX | 1992-08-18 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Instratek, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Instratek, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Instratek, Inc.” (first 1992, latest 2014), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Instratek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instratek, Inc. is 90 days.
Which FDA product codes appear under Instratek, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 3); HTN (Washer, Bolt Nut, 3); HWC (Screw, Fixation, Bone, 3).
Next steps
- See all 10 Instratek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Instratek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.