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)
Mar 14, 2018Zimmer Biomet, Inc.
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 8005083
Terminated		 HSBK972183
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
Terminated		 HSBK100238
Aug 7, 2017Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
Terminated		 HSBK100238

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