UNICONDYLAR INTERPOSITIONAL SPACER
FDA 510(k) clearance K003269 · decided 2001-01-04
Clearance details
- K-number
- K003269
- Device name
- UNICONDYLAR INTERPOSITIONAL SPACER
- Applicant
- Sulzer Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-10-18
- Decision date
- 2001-01-04
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HSH
- Device class
- 2
- Regulation number
- 888.3590
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS (K073233) | Advanced Bio-Surfaces, Inc. | 2008-01-28 |
| ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 (K053094) | Advanced Bio-Surfaces, Inc. | 2006-02-06 |
| KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (K033242) | Imaging Therapeutics, Inc. | 2003-12-31 |
| OTI UNICONDULAR INTERPOSITIONAL SPACER (K022779) | Osteoimplant Technology, Inc. | 2002-11-20 |
Recalls involving this device
No recalls on record reference this clearance.