The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Peba Anchor (multiple Sizes).
| Device ID | K951451 |
| 510k Number | K951451 |
| Device Name: | PEBA ANCHOR (MULTIPLE SIZES) |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Contact | Dthomas M Mcintosh |
| Correspondent | Dthomas M Mcintosh ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-10-31 |