The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for 12mm And 13mm Tibial Nails.
| Device ID | K130625 |
| 510k Number | K130625 |
| Device Name: | 12MM AND 13MM TIBIAL NAILS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. Unit B6 Torrance, CA 90501 |
| Contact | Allyson Parks |
| Correspondent | Allyson Parks ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 Beech Ave. Unit B6 Torrance, CA 90501 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-08 |
| Decision Date | 2013-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848665029673 | K130625 | 000 |
| 00848665029611 | K130625 | 000 |