The following data is part of a premarket notification filed by Acuitive Technologies, Inc. with the FDA for Citrespline And Citrelock Acl Implants.
| Device ID | K210239 |
| 510k Number | K210239 |
| Device Name: | CITRESPLINE And CITRELOCK ACL Implants |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-29 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810027270665 | K210239 | 000 |
| 00810027270580 | K210239 | 000 |
| 00810027270597 | K210239 | 000 |
| 00810027270603 | K210239 | 000 |
| 00810027270610 | K210239 | 000 |
| 00810027270627 | K210239 | 000 |
| 00810027270634 | K210239 | 000 |
| 00810027270641 | K210239 | 000 |
| 00810027270658 | K210239 | 000 |
| 00810027270573 | K210239 | 000 |