Synovis Surgical Innovations: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Synovis Surgical Innovations” (first 2003, latest 2013), plus 1 PMA decision, across 5 product codes in 2 review panels. Median 510(k) review time under this name: 62 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 | 0 | — |
| 2013 | 1 | 219 |
| 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 |
|---|---|---|---|
| FTM | Mesh, Surgical | 4 | 4 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| DRB | Stylet, Catheter | 1 | 1 |
| LXA | Tissue Graft Of 6mm And Greater | 1 | 0 |
| OXE | Mesh, Surgical, Collagen, Staple Line Reinforcement | 1 | 1 |
Review panels
Most recent Synovis Surgical Innovations 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | DXZ | 2013-03-08 | 219 |
| K083039 | VERITAS COLLAGEN MATRIX (DRY) | FTM | 2008-11-26 | 43 |
| K062915 | VERITAS COLLAGEN MATRIX | FTM | 2006-12-06 | 70 |
| K041669 | VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD | FTM | 2004-10-27 | 128 |
| K040415 | PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT | DXZ | 2004-04-14 | 56 |
| K040119 | PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION | FTM | 2004-03-17 | 57 |
| K040001 | STEERABLE STYLET | DRB | 2004-03-09 | 67 |
| K030879 | VERITAS COLLAGEN MATRIX | OXE | 2003-04-24 | 35 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P780002 | PMA | DARDIK BIOGRAFT | 1979-01-17 |
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2015-05-02.
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.
- Synovis Life Technologies, Inc. (9 510(k)s)
- Synovis Micro Companies Alliance, Inc. (5 510(k)s)
- Synovis Orthopedic & Woundcare (3 510(k)s)
- Synovis Life Technologies. Inc. (A Subsidiary of Baxter (1 510(k)s)
- Synovis Life Technologies, Inc. (Baxter International Inc.) (1 510(k)s)
- Synovis Micro Companies Alliance A Subsidiary of Baxter Int (1 510(k)s)
- Synovis Orthopedic and Woundcare, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synovis Surgical Innovations?
FDA lists 8 510(k) clearances under the applicant name “Synovis Surgical Innovations” (first 2003, latest 2013), plus 1 PMA decision, across 5 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 Synovis Surgical Innovations?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synovis Surgical Innovations is 62 days.
Which FDA product codes appear under Synovis Surgical Innovations?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 4); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); DRB (Stylet, Catheter, 1).
Next steps
- See all 8 Synovis Surgical Innovations clearances with predicates and recalls
- Run predicate analysis for product code FTM, Synovis Surgical Innovations'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.