Linvatec Corp.: FDA clearances and approvals
Linvatec Corp. has 93 FDA 510(k) clearances (first 1992, latest 2009), across 23 product codes in 7 review panels. Median 510(k) review time: 88 days. openFDA lists 56 product recalls by a recalling firm named Linvatec Corp.
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 | 19 | 19 |
| HWC | Screw, Fixation, Bone | 17 | 17 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 11 | 11 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 10 | 10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 4 | 4 |
| JOS | Electrode, Electrosurgical | 3 | 3 |
| DZI | Drill, Bone, Powered | 2 | 2 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 | 2 |
Plus 13 more product codes.
Review panels
- Orthopedic (62)
- General and Plastic Surgery (17)
- Ear, Nose and Throat (5)
- Obstetrics and Gynecology (3)
- Dental (2)
- Gastroenterology and Urology (2)
- Neurology (2)
Most recent Linvatec Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092998 | CONMED LINVATEC INTERCEPT IMPLANT | MBI | 2009-12-23 | 86 |
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM | MBI | 2009-06-23 | 27 |
| K090835 | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR | MAI | 2009-06-22 | 87 |
| K090186 | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES | MAI | 2009-04-10 | 74 |
| K083281 | EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA- | GEI | 2009-02-25 | 110 |
| K060198 | MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW | HRX | 2006-05-11 | 105 |
| K060270 | MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL | DZI | 2006-04-10 | 68 |
| K060260 | MICROPOWER HAND PIECE HIGH SPEED DRILL | HBC | 2006-04-10 | 68 |
| K050519 | ADVANCED TURBO DRIVE SYSTEM | GEY | 2005-05-17 | 77 |
| K050497 | BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET | HWC | 2005-03-25 | 25 |
83 earlier clearances. See the full list in Caduvo.
Recalls
56 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2008-02-21.
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 Linvatec Corp. have?
Linvatec Corp. has 93 FDA 510(k) clearances (first 1992, latest 2009), across 23 product codes in 7 review panels.
How long does FDA take to clear Linvatec Corp.'s 510(k)s?
The median time from FDA receipt to decision across Linvatec Corp.'s cleared 510(k)s is 88 days.
What devices does Linvatec Corp. make?
Its most frequent FDA product codes are HRX (Arthroscope, 19); HWC (Screw, Fixation, Bone, 17); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 11).
Has Linvatec Corp. had device recalls?
openFDA lists 56 product recalls in 6 recall events by a recalling firm whose name matches Linvatec Corp; the most recent began 2008-02-21. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 93 Linvatec Corp. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Linvatec Corp.'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.