510(k) K110029

CONSERVE BIO FOAM SHELL by Wrightmedicaltechnologyinc — Product Code KWA

K110029 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "CONSERVE BIO FOAM SHELL". The FDA issued a decision of Substantially Equivalent on April 19, 2011. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2011
Date Received
January 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type