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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010619112 | K972326 | 000 |
| 03596010502438 | K972326 | 000 |
| 03596010502421 | K972326 | 000 |
| 03596010502414 | K972326 | 000 |
| 03596010495457 | K972326 | 000 |
| 03596010495440 | K972326 | 000 |
| 03596010495433 | K972326 | 000 |
| 03596010495426 | K972326 | 000 |
| 03596010485670 | K972326 | 000 |
| 03596010485663 | K972326 | 000 |
| 03596010485656 | K972326 | 000 |
| 00885554014686 | K972326 | 000 |
| 00885554014136 | K972326 | 000 |
| 03596010502445 | K972326 | 000 |
| 03596010505125 | K972326 | 000 |
| 03596010585998 | K972326 | 000 |
| 03596010584465 | K972326 | 000 |
| 03596010581044 | K972326 | 000 |
| 03596010581037 | K972326 | 000 |
| 03596010581020 | K972326 | 000 |
| 03596010581013 | K972326 | 000 |
| 03596010533845 | K972326 | 000 |
| 03596010533838 | K972326 | 000 |
| 03596010533821 | K972326 | 000 |
| 03596010532213 | K972326 | 000 |
| 03596010532206 | K972326 | 000 |
| 03596010532190 | K972326 | 000 |
| 00885554012835 | K972326 | 000 |