The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Es Trochanteric Nail, Left And Right, 10mm.
| Device ID | K103533 |
| 510k Number | K103533 |
| Device Name: | ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance, CA 90501 |
| Contact | Julie Glendrange |
| Correspondent | Julie Glendrange ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE 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 | 2010-12-01 |
| Decision Date | 2011-01-19 |
| Summary: | summary |