The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Titanium Hybrid Femoral Stem.
| Device ID | K945783 |
| 510k Number | K945783 |
| Device Name: | ORTHOMET TITANIUM HYBRID FEMORAL STEM |
| Classification | Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Applicant | ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Contact | David A Cannistraci |
| Correspondent | David A Cannistraci ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis, MN 55439 -2713 |
| Product Code | JDG |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-25 |
| Decision Date | 1995-05-30 |