The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Peba Anchor/suture Combination.
| Device ID | K972326 |
| 510k Number | K972326 |
| Device Name: | PEBA ANCHOR/SUTURE COMBINATION |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Contact | Jeffrey B Skiba |
| Correspondent | Jeffrey B Skiba ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-23 |
| Decision Date | 1998-02-06 |
| Summary: | summary |