The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Ha Porous Acetabular System (ha/csti).
| Device ID | K972393 |
| 510k Number | K972393 |
| Device Name: | INTER-OP HA POROUS ACETABULAR SYSTEM (HA/CSTI) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jacquelyn Hughes |
| Correspondent | Jacquelyn Hughes SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-26 |
| Decision Date | 1997-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024181939 | K972393 | 000 |
| 00889024181922 | K972393 | 000 |
| 00889024181915 | K972393 | 000 |