Atlas FDA

TITANIUM LOW PROFILE SCREWS

FDA 510(k) clearance K991807 · decided 1999-07-08

Clearance details

K-number
K991807
Device name
TITANIUM LOW PROFILE SCREWS
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1999-05-26
Decision date
1999-07-08
Days to decision
43 days
Clearance type
Traditional
Product code
LPH
Device class
2
Regulation number
888.3358
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
Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammat recall (Z-0621-2021)Biomet, Inc.2020-12-17
Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East B recall (Z-2135-2011)Biomet, Inc.2011-05-03

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