510(k) K070695

ZIMMER PATELLOFEMORAL JOINT PROSTHESIS by Zimmer, Inc. — Product Code KRR

K070695 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER PATELLOFEMORAL JOINT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on June 7, 2007. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Zimmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2007
Date Received
March 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3540
Review Panel
OR
Submission Type