The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Trochanteric Nails And Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N.
| Device ID | K133081 |
| 510k Number | K133081 |
| Device Name: | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance, CA 90505 |
| Contact | Kazunori Miyahara |
| Correspondent | Kazunori Miyahara ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance, CA 90505 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2013-12-31 |
| Summary: | summary |