Atlas FDA

TITANIUM PEDIATRIC FEMORAL NAIL

FDA 510(k) clearance K993956 · decided 1999-12-20

Clearance details

K-number
K993956
Device name
TITANIUM PEDIATRIC FEMORAL NAIL
Applicant
Biomet, Inc.
Decision
Substantially Equivalent
Date received
1999-11-22
Decision date
1999-12-20
Days to decision
28 days
Clearance type
Special
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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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkw recall (Z-2302-2009)EBI, L.P.2009-09-22
Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkw recall (Z-2303-2009)EBI, L.P.2009-09-22
Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkw recall (Z-2304-2009)EBI, L.P.2009-09-22
Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; Biomet, 100 Interpace Parkw recall (Z-2305-2009)EBI, L.P.2009-09-22
Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; Biomet Spine, Parsippany, NJ The sc recall (Z-2306-2009)EBI, L.P.2009-09-22
Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA, Biomet Spine, Parsippany, NJ 070 recall (Z-2307-2009)EBI, L.P.2009-09-22
Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA, Biomet Spine, Parsippany, NJ 0 recall (Z-2308-2009)EBI, L.P.2009-09-22
Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA, Biomet Spine, Parsippany, NJ 0 recall (Z-2309-2009)EBI, L.P.2009-09-22
Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in recall (Z-2310-2009)EBI, L.P.2009-09-22
Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made i recall (Z-2311-2009)EBI, L.P.2009-09-22
Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; Biomet Spine, Parsippany, NJ 07054 recall (Z-2312-2009)EBI, L.P.2009-09-22

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