510(k) K062960

CONSERVE FEMORAL RESURFACING COMPONENT by Wrightmedicaltechnologyinc — Product Code KXA

K062960 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "CONSERVE FEMORAL RESURFACING COMPONENT". The FDA issued a decision of Substantially Equivalent on December 1, 2006. The device falls under product code KXA (Prosthesis, Hip, Femoral, Resurfacing), a Class II device regulated under 21 CFR 888.3400. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2006
Date Received
September 29, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral, Resurfacing
Device Class
Class II
Regulation Number
888.3400
Review Panel
OR
Submission Type