510(k) K013982

KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT by Kinamed, Inc. — Product Code KRR

K013982 is an FDA 510(k) premarket notification submitted by Kinamed, Inc. for the device "KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT". The FDA issued a decision of Substantially Equivalent on May 21, 2002. 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. Kinamed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2002
Date Received
December 3, 2001
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