The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Unicondylar Interpositional Spacer.
| Device ID | K003269 |
| 510k Number | K003269 |
| Device Name: | UNICONDYLAR INTERPOSITIONAL SPACER |
| Classification | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | HSH |
| CFR Regulation Number | 888.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-18 |
| Decision Date | 2001-01-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024487031 | K003269 | 000 |
| 00889024487024 | K003269 | 000 |