Parcus Medical
Parcus Medical appears in FDA public data with 0 recalls, 31 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Feb 17, 2017 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Sep 18, 2023.
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Summary
- Total Recalls
- 0
- 510(k) Clearances
- 31
- Inspections
- 2
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 17, 2017 | Sarasota, FL | Devices | No Action Indicated (NAI) | 3007319107 |
| Aug 16, 2013 | Sarasota, FL | Devices | No Action Indicated (NAI) | 3007319107 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K232513 | X-Twist Biocomposite Suture Anchor | Sep 18, 2023 |
| K221502 | Parcus Synd-EZ SS | Jul 26, 2022 |
| K221135 | X-Twist PEEK Suture Anchor | May 19, 2022 |
| K212739 | ActiFlip | Oct 6, 2021 |
| K202662 | Parcus Titanium Interference Screws | Feb 22, 2021 |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked… | Oct 28, 2020 |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Jul 23, 2020 |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Jan 23, 2020 |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip | Jan 16, 2020 |
| K192964 | Parcus Synd-EZ SS | Nov 22, 2019 |
| K192824 | Parcus Knotless AP Suture Anchors | Nov 2, 2019 |
| K191783 | Parcus Synd-EZ Ti | Oct 9, 2019 |
| K190375 | Parcus ATLAS | Apr 24, 2019 |
| K183501 | Parcus Twist AP Suture Anchors | Mar 15, 2019 |
| K183331 | Parcus GFS BTB | Feb 7, 2019 |
| K170877 | Parcus SLiK Fix Screw | Jun 2, 2017 |
| K170327 | Parcus SLiK Anchors | Mar 30, 2017 |
| K162198 | GFS Ultimate | Nov 18, 2016 |
| K152711 | Parcus GFS Naked | Nov 20, 2015 |
| K133757 | GFS II STANDARD, GFS II LARGE, GFS MIMI | Feb 4, 2014 |