510(k) K072121
K072121 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER". The FDA issued a decision of Substantially Equivalent on January 7, 2008. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2008
- Date Received
- August 1, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type