The following data is part of a premarket notification filed by Parcus Medical Llc with the FDA for X-twist Peek Suture Anchor.
| Device ID | K221135 |
| 510k Number | K221135 |
| Device Name: | X-Twist PEEK Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Parcus Medical LLC 6423 Parkland Drive Sarasota, FL 34243 |
| Contact | Calen Souther |
| Correspondent | Calen Souther Parcus Medical LLC 6423 Parkland Drive Sarasota, FL 34243 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-19 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816342025386 | K221135 | 000 |
| 00816342025379 | K221135 | 000 |
| 00816342025362 | K221135 | 000 |
| 00816342025355 | K221135 | 000 |
| 00816342025348 | K221135 | 000 |
| 00816342025331 | K221135 | 000 |
| 00816342025324 | K221135 | 000 |
| 00816342025317 | K221135 | 000 |
| 00816342025300 | K221135 | 000 |