The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Titanium Nitride Coated Hemi-head Component.
| Device ID | K924050 |
| 510k Number | K924050 |
| Device Name: | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1993-08-25 |