The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Orthomet Acetabular Cup System.
| Device ID | K931333 |
| 510k Number | K931333 |
| Device Name: | ORTHOMET ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1993-03-16 |
| Decision Date | 1994-10-14 |