Synvasive Technology, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Synvasive Technology, Inc.” (first 1994, latest 2011), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 261 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 |
|---|---|---|---|
| HTZ | Instrument, Cutting, Orthopedic | 2 | 2 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| LXI | Guide, Drill, Ligament | 1 | 1 |
Review panels
Most recent Synvasive Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | ONN | 2011-03-22 | 538 |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | ONN | 2007-04-04 | 83 |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | HWE | 1997-08-26 | 54 |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | HTY | 1996-09-23 | 154 |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | JDW | 1995-08-18 | 227 |
| K934336 | SPINALPLANE | HSZ | 1995-03-10 | 549 |
| K933933 | CEBOPLANE | HTZ | 1994-04-15 | 247 |
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | LXI | 1994-04-07 | 427 |
| K932869 | ARTHROPLANE | HRX | 1994-03-25 | 284 |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | HTZ | 1994-01-07 | 275 |
Recalls
4 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2018-07-27.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Synvasive Technology, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Synvasive Technology, Inc.” (first 1994, latest 2011), across 8 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 Synvasive Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synvasive Technology, Inc. is 261 days.
Which FDA product codes appear under Synvasive Technology, Inc.?
The most frequent FDA product codes under this applicant name are HTZ (Instrument, Cutting, Orthopedic, 2); ONN (Intraoperative Orthopedic Joint Assessment Aid, 2); HRX (Arthroscope, 1).
Next steps
- See all 10 Synvasive Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HTZ, Synvasive Technology, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.