Atlas FDA

TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES

FDA 510(k) clearance K982953 · decided 1998-10-21

Clearance details

K-number
K982953
Device name
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1998-08-24
Decision date
1998-10-21
Days to decision
58 days
Clearance type
Traditional
Product code
HSB
Device class
2
Regulation number
888.3020
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
TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2288-2009)EBI, L.P.2009-09-22
TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; Biomet, 100 recall (Z-2289-2009)EBI, L.P.2009-09-22
Uniflex Ti Buttress Thread Screw; TI Screw Buttress Thread Trauma Fixation Systems, Rx onl recall (Z-2116-2009)EBI, L.P.2009-09-21
Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 3296 recall (Z-0918-05)EBI, L.P.2005-06-22

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