The following data is part of a premarket notification filed by Topez Orthopedics, Inc with the FDA for Topez Total Ankle Replacement.
| Device ID | K051023 |
| 510k Number | K051023 |
| Device Name: | TOPEZ TOTAL ANKLE REPLACEMENT |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | TOPEZ ORTHOPEDICS, INC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward TOPEZ ORTHOPEDICS, INC 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-22 |
| Decision Date | 2005-11-15 |
| Summary: | summary |