Panels › Orthopedic › Product code HSB · Class 2

Rod, Fixation, Intramedullary And Accessories

Regulation 888.3020

20510(k)s in 12 months (532 all time)

19recalls in 12 months (690 all time)

680recalls that name a 510(k)

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Top companies in HSB

Company	510(k)s	Recalls
Zimmer Biomet, Inc.	0	295
DePuy Orthopaedics, Inc.	9	116
Zimmer GmbH	23	50
Stryker	12	37
Howmedica Osteonics	39	0
OrthoPediatrics Corp.	7	31
Ebi, L.P.	1	31
Advanced Orthopaedic Solutions, Inc.	15	12
NuVasive Specialized Orthopedics	18	9
Synthes (Usa)	23	4

Date	Firm and product	Code	Linked 510(k)
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 280 mm, Item Number: 814509280 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 130 9 mm x 260 mm, Item Number: 814509260 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail 130 9 mm x 180 mm, Item Number: 814509180 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 460 mm, Item Number: 814413460 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 420 mm, Item Number: 814413420 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 400 mm, Item Number: 814413400 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 380 mm, Item Number: 814413380 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number: 814413360 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number: 814413340 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 320 mm, Item Number: 814413320 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 300 mm, Item Number: 814413300 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 280 mm, Item Number: 814413280 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number: 814413260 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 460 mm, Item Number: 814411460 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 440 mm, Item Number: 814411440 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 420 mm, Item Number: 814411420 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 400 mm, Item Number: 814411400 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 380 mm, Item Number: 814411380 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number: 814411360 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 340 mm, Item Number: 814411340 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number: 814411320 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number: 814411260 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number: 814409460 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number: 814409440 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 420 mm, Item Number: 814409420 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 400 mm, Item Number: 814409400 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 380 mm, Item Number: 814409380 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 360 mm, Item Number: 814409360 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 340 mm, Item Number: 814409340 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number: 814409320 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number: 814409300 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 280 mm, Item Number: 814409280 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number: 814409260 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 460 mm, Item Number: 814313460 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number: 814313440 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 420 mm,Item Number: 814313420 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number: 814313400 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 380 mm, Item Number: 814313380 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number: 814313360 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 340 mm, Item Number: 814313340 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 320 mm, Item Number: 814313320 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number: 814313300 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number: 814313280 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number: 814313260 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number: 814313180 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number: 814311460 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number: 814311440 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number: 814311420 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 400 mm, Item Number: 814311400 Terminated	HSB	K100238
Sep 13, 2018	Zimmer Biomet, Inc. Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number: 814311380 Terminated	HSB	K100238

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