The following data is part of a premarket notification filed by Parcus Medical, Llc with the FDA for Parcus Twist Ap Suture Anchors.
| Device ID | K183501 |
| 510k Number | K183501 |
| Device Name: | Parcus Twist AP Suture Anchors |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Parcus Medical, LLC 6423 Parkland Dr Sarasota, FL 34231 |
| Contact | Paul Vagts |
| Correspondent | Paul Vagts Parcus Medical, LLC 6423 Parkland Dr Sarasota, FL 34231 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M685113600 | K183501 | 000 |
| 00816342024914 | K183501 | 000 |
| 00816342024907 | K183501 | 000 |
| 00816342024891 | K183501 | 000 |
| 00816342024884 | K183501 | 000 |
| 00816342024877 | K183501 | 000 |
| 00816342024860 | K183501 | 000 |
| 00816342024853 | K183501 | 000 |
| 00816342024846 | K183501 | 000 |
| 00816342024839 | K183501 | 000 |
| 00816342025232 | K183501 | 000 |
| 00816342025225 | K183501 | 000 |
| 00816342024938 | K183501 | 000 |
| 00816342025287 | K183501 | 000 |
| M685113590 | K183501 | 000 |
| M685113580 | K183501 | 000 |
| M685113570 | K183501 | 000 |
| M685111270 | K183501 | 000 |
| M685111260 | K183501 | 000 |
| M685111250 | K183501 | 000 |
| M68510798T0 | K183501 | 000 |
| M68510797T0 | K183501 | 000 |
| M68510796T0 | K183501 | 000 |
| 00816342024945 | K183501 | 000 |
| 00816342024921 | K183501 | 000 |
| 00816342025157 | K183501 | 000 |