The following data is part of a premarket notification filed by Acuitive Technologies, Inc. with the FDA for The Citrefix Knotless Suture Anchor.
| Device ID | K203334 |
| 510k Number | K203334 |
| Device Name: | The Citrefix Knotless Suture Anchor |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Acuitive Technologies, Inc. 50 Commerce Drive Allendale, NJ 07401 |
| Contact | Matthew Poggie |
| Correspondent | Robert A Poggie BioVera, Inc 65 Promenade Saint Louis Notre-dame-de-l'lle-perrot, CA J7v7p2 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-02-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810027270887 | K203334 | 000 |
| 00810027270870 | K203334 | 000 |
| 00810027270863 | K203334 | 000 |
| 00810027270856 | K203334 | 000 |
| 00810027270429 | K203334 | 000 |
| 00810027270412 | K203334 | 000 |
| 00810027270405 | K203334 | 000 |
| 00810027270382 | K203334 | 000 |