The following data is part of a premarket notification filed by B-one Ortho, Corp with the FDA for Onefix Biocomposite Anchors, Onefix Biocomposite Small Anchors, Onefix All Suture Anchors, Onefix Interference Screws, Onefix Cannula System.
| Device ID | K212912 |
| 510k Number | K212912 |
| Device Name: | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | b-ONE ORTHO, Corp 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 |
| Contact | Allison Gecik |
| Correspondent | Allison Gecik b-ONE ORTHO, Corp 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 |
| Product Code | MAI |
| Subsequent Product Code | HRX |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-13 |
| Decision Date | 2021-11-04 |