510(k) K003269
K003269 is an FDA 510(k) premarket notification submitted by Sulzer Orthopedics, Inc. for the device "UNICONDYLAR INTERPOSITIONAL SPACER". The FDA issued a decision of Substantially Equivalent on January 4, 2001. The device falls under product code HSH (Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)), a Class II device regulated under 21 CFR 888.3590. Sulzer Orthopedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 2001
- Date Received
- October 18, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- Device Class
- Class II
- Regulation Number
- 888.3590
- Review Panel
- OR
- Submission Type