510(k) K082673

CONSERVE PRESSFIT FEMORAL COMPONENT by Wrightmedicaltechnologyinc — Product Code KXA

K082673 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "CONSERVE PRESSFIT FEMORAL COMPONENT". The FDA issued a decision of Substantially Equivalent on December 12, 2008. 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 12, 2008
Date Received
September 15, 2008
Clearance Type
Traditional
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