Atlas FDA

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

FDA 510(k) clearance K921182 · decided 1993-07-23

Clearance details

K-number
K921182
Device name
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1992-03-10
Decision date
1993-07-23
Days to decision
500 days
Clearance type
Traditional
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Warsaw, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok fini recall (Z-0076-2008)Biomet, Inc.2007-10-31
Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO a recall (Z-0077-2008)Biomet, Inc.2007-10-31

PMA approvals by this applicant

RecordFirmDate
C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009)Biomet, Inc.2011-02-11
C2A-TAPER ACETABULAR SYSTEM (P050009/S004)Biomet, Inc.2009-04-17
C2A TAPER ACETABULAR SYSTEM (P050009/S007)Biomet, Inc.2009-03-13
C2-A TAPER ACETABULAR SYSTEM (P050009/S005)Biomet, Inc.2007-11-30
C2A-TAPER ACETABULAR SYSTEM (P050009/S002)Biomet, Inc.2006-06-16
C2A-TAPER ACETABULAR SYSTEM (P050009/S001)Biomet, Inc.2006-02-01
C2 A-TAPER ACETABULAR SYSTEM (P050009)Biomet, Inc.2005-12-16