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FDA product code HXB · Class 1 · Orthopedic

3,116
Registered devices
607
Adverse events
3
Recalls
15
510(k) clearances

Devices with this code

Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.General Instruments — ALPHATEC SPINE, INC.N/A — Ortho Development CorporationNorthStar — Seaspine Orthopedics CorporationCoral — Seaspine Orthopedics CorporationMalibu — Seaspine Orthopedics CorporationLife Instruments — Life Instrument CorporationSklar® — SKLAR CORPORATIONSTARFIRE™ Pedicle Screw System — Choice Spine, LPSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.Sklar® — SKLAR CORPORATIONMedicon — Medicon eG. Chirurgiemechaniker-GenossenschaftTOSCA — SIGNUS Medizintechnik GmbHPolaris 5.5 Spinal Fixation System — Highridge Medical, LLCPolaris 5.5 Spinal Fixation System — Highridge Medical, LLCArsenal — ALPHATEC SPINE, INC.Tecomet — TECOMET INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.General Instrument — ORTHOPEDIATRICS CORP.Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC.NA — DEPUY SPINE, LLCMedtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.

Recent recalls

DateFirmReason
2024-12-03Sklar InstrumentsReports of various packaging issues that may result in a breach of the sterile barrier.
2014-12-02Zimmer Trabecular Metal Technology, Inc.During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
2013-09-11SpineFrontier, Inc.Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.