The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Porous Revision Shell With Sealable Screwholes.
| Device ID | K970705 |
| 510k Number | K970705 |
| Device Name: | INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Shavawn Parduhn |
| Correspondent | Shavawn Parduhn 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 | 1997-02-26 |
| Decision Date | 1997-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024167018 | K970705 | 000 |
| 00889024181793 | K970705 | 000 |