Linvatec Biomaterials, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Linvatec Biomaterials, Ltd.” (first 2003, latest 2005), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 26 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CONMED, based on public ownership records.
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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
Review panels
- Orthopedic (7)
- Dental (1)
Most recent Linvatec Biomaterials, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052080 | MATRYX INTERFERENCE SCREW | HWC | 2005-08-25 | 23 |
| K042966 | DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H | MAI | 2004-11-19 | 22 |
| K042517 | BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS | JEY | 2004-10-08 | 23 |
| K042295 | SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 | HWC | 2004-09-16 | 23 |
| K041288 | MODIFICATION TO SMARTPIN | HTY | 2004-06-10 | 28 |
| K032894 | OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, | HWC | 2004-05-07 | 233 |
| K032447 | CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED | HWC | 2004-04-16 | 252 |
| K031981 | 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 | MAI | 2003-07-25 | 29 |
Recalls
openFDA lists no recalls under a recalling firm named Linvatec Biomaterials, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Linvatec Corp. (93 510(k)s)
- Linvatec Corporation D/B/A Conmed Linvatec (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Linvatec Biomaterials, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Linvatec Biomaterials, Ltd.” (first 2003, latest 2005), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Linvatec Biomaterials, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Linvatec Biomaterials, Ltd. is 26 days.
Which FDA product codes appear under Linvatec Biomaterials, Ltd.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 4); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 2); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 8 Linvatec Biomaterials, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Linvatec Biomaterials, Ltd.'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.