510(k) K093235

RINGLOC + HYBRID ACETABULAR SYSTEM by Biomet, Inc. — Product Code KWA

K093235 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "RINGLOC + HYBRID ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 2010. 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, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
October 15, 2009
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