510(k) K051348

CONSERVE TOTAL FEMORAL HEAD by Wrightmedicaltechnologyinc — Product Code JDL

K051348 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "CONSERVE TOTAL FEMORAL HEAD". The FDA issued a decision of Substantially Equivalent on August 19, 2005. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2005
Date Received
May 24, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type