ClearanceBrief
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

Company510(k)sRecalls
Zimmer Biomet, Inc.0295
DePuy Orthopaedics, Inc.9116
Zimmer GmbH2350
Stryker1237
Howmedica Osteonics390
OrthoPediatrics Corp.731
Ebi, L.P.131
Advanced Orthopaedic Solutions, Inc.1512
NuVasive Specialized Orthopedics189
Synthes (Usa)234
DateFirm and productCodeLinked 510(k)
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 360 mm, Item Number: 814311360
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 340 mm, Item Number: 814311340
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 320 mm, Item Number: 814311320
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 300 mm, Item Number: 814311300
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 280 mm, Item Number: 814311280
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 11 mm x 180 mm, Item Number: 814311180
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number: 814309460
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number: 814309440
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 420 mm, Item Number: 814309420
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number: 814309380
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number: 814309360
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number: 814309320
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number: 814309180
Terminated		 HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 9 mm x 280 mm, Item Number: 814309280
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number 814615360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number 814611400 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number 814611360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 13 mm x 360 mm, Item Number 814513360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 400 mm, Item Number 814511400 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 360 mm, Item Number 814511360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
Terminated		 HSBNone listed
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 360 mm, Item Number 814411360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 320 mm, Item Number 814411320 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 300 mm, Item Number 814409300 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 9 mm x 260 mm, Item Number 814409260 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 440 mm, Item Number 814313440 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 360 mm, Item Number 814313360 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 300 mm, Item Number 814313300 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 280 mm, Item Number 814313280 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 13 mm x 180 mm, Item Number 814313180 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 460 mm, Item Number 814311460 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 440 mm, Item Number 814311440 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238
Aug 8, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures
Terminated		 HSBK100238

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