The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Sb Anchor.
| Device ID | K942889 |
| 510k Number | K942889 |
| Device Name: | SB ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Contact | Thomas M Mcintosh |
| Correspondent | Thomas M Mcintosh ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1995-08-25 |