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

DateFirm and productCodeLinked 510(k)
Dec 17, 2020Biomet, Inc.
PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
Terminated
HSBK063570
Sep 18, 2020Merete Medical GmbH
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Terminated
HSBK181026
Sep 18, 2020Merete Medical GmbH
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Terminated
HSBK181026
Sep 18, 2020Merete Medical GmbH
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Terminated
HSBK181026
Sep 18, 2020Merete Medical GmbH
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Terminated
HSBK101939
Jul 24, 2020Nuvasive Specialized Orthopedics Inc
NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screw
Open, Classified
HSBK193016
K201567
Jun 16, 2020Stryker GmbH
Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliz
Terminated
HSBK003018
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilizati
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Tibia 5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliza
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded T2 Humerus 4x32 mm Catalog Number: 18964032S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabiliza
Terminated
HSBK003018
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Partially Threaded T2 Tibia 5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabili
Terminated
HSBK032244
Jun 16, 2020Stryker GmbH
Stryker End Cap T2 Humerus 6mm, 15mm height Catalog Number: 18300015S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bon
Terminated
HSBK011529
Jun 16, 2020Stryker GmbH
Stryker 1 End Cap T2 Humerus 6mm, 5mm height Catalog Number: 18300005S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bo
Terminated
HSBK011529
Jun 16, 2020Stryker GmbH
Stryker End Cap, Standard T2 Humerus 6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones
Terminated
HSBK011529
Jun 16, 2020Stryker GmbH
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Terminated
HSBK003018
Jun 16, 2020Stryker GmbH
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bon
Terminated
HSBK003018
Jun 16, 2020Stryker GmbH
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of
Terminated
HSBK032579
Oct 10, 2019Zimmer Biomet, Inc.
Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010 47249318011 47249318013 47249318014 47249318109 47249318110 47249318111 47249318113 47249318114 47249318209 47249318210 47
Terminated
HSBK091566
Oct 10, 2019Zimmer Biomet, Inc.
FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115 32855331161 32855331163 32855331165
Terminated
HSBK853250
Oct 10, 2019Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 0022
Terminated
HSBK142281
Aug 19, 2019OrthoPediatrics Corp
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation r
Terminated
HSBK172583
Aug 19, 2019OrthoPediatrics Corp
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (pr
Terminated
HSBK172583
Aug 19, 2019OrthoPediatrics Corp
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the int
Terminated
HSBK172583
May 29, 2019Pega Medical Inc.
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
Terminated
HSBK143355
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to s
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to
Terminated
HSBK100238
Oct 2, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabi
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number: 814615360
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 460 mm, Item Number: 814613460
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 440 mm, Item Number: 814613440
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 420 mm, Item Number: 814613420
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 400 mm, Item Number: 814613400
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 380 mm, Item Number: 814613380
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 360 mm, Item Number: 814613360
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 340 mm, Item Number: 814613340
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 320 mm, Item Number: 814613320
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 300 mm, Item Number: 814613300
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 280 mm, Item Number: 814613280
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 13 mm x 260 mm, Item Number: 814613260
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 460 mm, Item Number: 814611460
Terminated
HSBK100238
Sep 13, 2018Zimmer Biomet, Inc.
Affixus Hip Fracture Nail Left 130 11 mm x 440 mm, Item Number: 814611440
Terminated
HSBK100238

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