Innovasive Devices, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Innovasive Devices, Inc.” (first 1993, latest 2000), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 86 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 | 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 22 | 22 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 4 | 4 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HRX | Arthroscope | 1 | 1 |
| OCW | Endoscopic Tissue Approximation Device | 1 | 1 |
Review panels
Most recent Innovasive Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K994269 | TITAN RC TACK | MAI | 2000-01-10 | 21 |
| K993975 | ABSOLUTE ABSORBABLE INTERFERENCE SCREW | HWC | 1999-12-20 | 26 |
| K992458 | RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454 | MBI | 1999-10-14 | 83 |
| K992377 | RC TACK | MBI | 1999-10-08 | 85 |
| K990454 | BIO-INTERFERENCE SCREW | HWC | 1999-07-01 | 139 |
| K984490 | SUTURELESS ANCHOR | MAI | 1999-03-01 | 74 |
| K983560 | INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER | MBI | 1999-01-28 | 107 |
| K983056 | INNOVASIVE TIBIAL FASTENER | MBI | 1998-10-13 | 42 |
| K981340 | INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM | MAI | 1998-06-22 | 70 |
| K981193 | INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER | MBI | 1998-06-16 | 75 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Innovasive Devices, 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.
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.
- Innovasive, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Innovasive Devices, Inc.?
FDA lists 34 510(k) clearances under the applicant name “Innovasive Devices, Inc.” (first 1993, latest 2000), across 7 product codes in 3 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 Innovasive Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Innovasive Devices, Inc. is 86 days.
Which FDA product codes appear under Innovasive Devices, Inc.?
The most frequent FDA product codes under this applicant name are MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 22); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 4); HWC (Screw, Fixation, Bone, 3).
Next steps
- See all 34 Innovasive Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MBI, Innovasive Devices, 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.