510(k) K103755

TAPERLOC COMPLETE, SIZE 5 AND 6 by Biomet Manufacturing Corp — Product Code KWA

K103755 is an FDA 510(k) premarket notification submitted by Biomet Manufacturing Corp for the device "TAPERLOC COMPLETE, SIZE 5 AND 6". The FDA issued a decision of Substantially Equivalent on January 21, 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. Biomet Manufacturing Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2011
Date Received
December 23, 2010
Clearance Type
Special
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