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Bender
FDA product code HXW · Class 1 · Orthopedic
1,321
Registered devices
320
Adverse events
3
Recalls
3
510(k) clearances
Devices with this code
Arsenal — ALPHATEC SPINE, INC.NA — Zimmer, Inc.EXPEDIUM — Medos International SàrlVital MIS Spinal Fixation System — Highridge Medical, LLCANAX 5.5 SPINAL SYSTEM — CG MedTech Co.,Ltd.Zodiac — ALPHATEC SPINE, INC.Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System — Highridge Medical, LLCNA — DEPUY SPINE, LLCEPS Plating System — GRAMERCY EXTREMITY ORTHOPEDICS LLCSurgical Instrument — Jeil Medical CorporationInvictus — ALPHATEC SPINE, INC.CENTURION — Orthofix US LLCRIVA Posterior Fixation System — XENIX MEDICAL LLCGeneral Instrument — ORTHOPEDIATRICS CORP.Tecomet — TECOMET INC.RAYHACK — WRIGHT MEDICAL TECHNOLOGY, INC.Daytona — Seaspine Orthopedics CorporationArsenal or Invictus — ALPHATEC SPINE, INC.SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM — Pioneer Surgical Technology, Inc.NEOFIT — IN2BONESVitality® — ZIMMER SPINE, INC.Invictus — ALPHATEC SPINE, INC.Streamline OCT — Xtant Medical Holdings, Inc.NA — DEPUY SPINE, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-30 | Aesculap Implant Systems LLC | Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2021-06-30 | Aesculap Implant Systems LLC | Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2014-12-15 | Synthes, Inc. | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay ma |
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