The following data is part of a premarket notification filed by Acuitive Technologies, Inc. with the FDA for Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline Acl, And Citrelock Acl.
| Device ID | K220833 |
| 510k Number | K220833 |
| Device Name: | Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, And Citrelock ACL |
| 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 J7W3J6 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-11-04 |