Conmed Linvatec: FDA clearances and approvals
Conmed Linvatec has 21 FDA 510(k) clearances (first 2005, latest 2011), across 11 product codes in 5 review panels. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
| FRG | Wrap, Sterilization | 1 | 1 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
| HBC | Motor, Drill, Electric | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (13)
- General Hospital (3)
- General and Plastic Surgery (3)
- Gastroenterology and Urology (1)
- Neurology (1)
Most recent Conmed Linvatec 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111779 | Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 | MBI | 2011-08-08 | 45 |
| K102410 | MATRYX INTERFERENCE SCREW (5.0-6.5MM) | HWC | 2010-12-21 | 119 |
| K102339 | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE | GAT | 2010-11-23 | 97 |
| K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 | MAI | 2010-08-26 | 128 |
| K092898 | CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES | MAI | 2009-10-19 | 28 |
| K090560 | CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS | KCT | 2009-06-29 | 119 |
| K083161 | ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) | HRX | 2009-03-27 | 151 |
| K080531 | CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY | KCT | 2008-09-05 | 192 |
| K072291 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR | HWC | 2008-07-14 | 333 |
| K080444 | CONMED LINVATEC OSPREY DRILL SYSTEM | HBC | 2008-04-02 | 43 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Conmed Linvatec.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Conmed Linvatec have?
Conmed Linvatec has 21 FDA 510(k) clearances (first 2005, latest 2011), across 11 product codes in 5 review panels.
How long does FDA take to clear Conmed Linvatec's 510(k)s?
The median time from FDA receipt to decision across Conmed Linvatec's cleared 510(k)s is 89 days.
What devices does Conmed Linvatec make?
Its most frequent FDA product codes are HRX (Arthroscope, 4); HWC (Screw, Fixation, Bone, 4); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 3).
Has Conmed Linvatec had device recalls?
openFDA lists no recalls under a recalling firm name matching Conmed Linvatec. Related entities may recall under other names.
Next steps
- See all 21 Conmed Linvatec clearances with predicates and recalls
- Run predicate analysis for product code HRX, Conmed Linvatec's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.