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Danek Medical, Inc.

United StatesFDA applicant, unverified

Devices
56

What Danek Medical, Inc. makes

Danek Medical, Inc. manufactures spinal fixation hardware, including modifications of the TSRH and ZPlate-ATL systems, pedicle screw plating (Townley system), spinal rods (Precision Rod Set), and overhead arm slings. Their portfolio also covers diagnostic tools like the SpinalScope, soft goods such as splints and lumbar support devices, and accessories like side rail pads and clavicular straps.

The company’s devices are regulated under FDA 510(k) clearance, spanning Class I and Class II classifications. Products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue56

Newest first, rows 1-50 of 56

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  • Modification Of Tsrh Spinal System Ref K984522

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Overhead Arm Slings Ref K823811

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cd Horizon Spinal System Ref K993810

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danek Precision Rod Set Ref K896254

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Spine Fixation Ref K943827

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification Of The Zplate-Atl Anterior Fixation System Ref K990603

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danek Spinalscope Ref K901692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Side Rail Pads Ref K823821

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Clavical Strap Ref K823809

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Townley Pedicle Screw Plating System Ref K970599

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Softgood Products And Splints Ref K803239

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Lumbosacral Support Ref K823823

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tsrh Spinal System (Add'l Sizes Of Hooks) Ref K901005

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danekscope Opti-Probe Ref K943676

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Luque Iii Spinal System And Luque Mini-Set Ref K890192

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification Of Townley Pedicle Screw Plating System Ref K982154

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tsrh Open Head Bone Screw Ref K911319

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danek Ring Fixator (Drf) Ref K890814

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Chiba Spinal System Ref K895978

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sternotomy Cable, Songer Cable System Ref K903676

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tsrh Offset And Side-Loading Hooks Ref K903461

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Axial And Offset Crosslink Plates Ref K896740

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Microsurgical Instruments Ref K911300

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danekscope And Accessories Ref K911729

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Various Arm Sling Ref K823808

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Knight Sacral Screw Ref K902775

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Songer(Tm) Cable System Ref K913735

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Olive K-Wires Ref K903105

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Inclusive Endoscope Ref K943356

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cast Toe Cover Ref K823819

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modification To Zplate-Atl Anterior Fixation System Ref K982875

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Abduction Pillow Ref K823820

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Crosslink Plate Ref K911307

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danek Sacral Hook, Modification Ref K911379

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Danek Sacral Hook Ref K901590

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tsrh Sacral L-Connector Ref K901587

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Traction Accessories Ref K823813

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Modification To Tenor Spinal System-Rod/Bolt Connector Ref K991528

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tsrh Variable Angle Sacral Screw Ref K904243

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Catheter Holder Ref K823818

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ray Sacral Fixation System Ref K904520

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • A.C. Splint Ref K823810

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Danek Wrist Fixator Ref K891066

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hot/Cold Pack Holders Ref K823814

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Various Supports And Splints Ref K823812

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ankle Weights Ref K823822

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Songer Wiring System Ref K892651

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hsc Unit Rod Ref K896603

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bone Graft Washer, Model 9090114 - 9090118 Ref K994122

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tsrh(R) Top Tight T-Bolt-Vari Angle/Screw/Paragon Ref K933205

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 56

Showing 1-50 of 56

Frequently asked questions

How many devices does Danek Medical, Inc. have in the registry?

The registry currently lists 56 devices for Danek Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Danek Medical, Inc.'s devices?

Among its 50 most recently registered devices, Danek Medical, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Danek Medical, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Danek Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Danek Medical, Inc. in the registry?

The most recently registered devices listed for Danek Medical, Inc. include MODIFICATION OF TSRH SPINAL SYSTEM, OVERHEAD ARM SLINGS, CD HORIZON SPINAL SYSTEM and DANEK PRECISION ROD SET.

Generated automatically from registry data and not verified by a human reviewer.