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Orthopedic Systems, Inc.

United StatesFDA applicant, unverified

Devices
90
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue90

Newest first, rows 1-50 of 90

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  • Blakemore Retainer Ref K880253

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

  • Extremity Elevator Ref K870125

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

  • Tendon Leader Ref K853764

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

  • Freeman Total Hip System Ridged Stem Ref K890331

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

  • Osi Rizzoli Trauma Table (Electric Version) Ref K881060

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

  • Tlc Support Products Ref K803029

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

  • Universal Cemented Cup Ref K894249

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

  • Moore Hip Prosthesis Solid Stem Ref K874599

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

  • Park City Shoulder Positioner Ref K910031

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

  • Octagonal Aluminum Framing System Ref K823372

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

  • Traction-Steel Framing System Ref K823395

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

  • Moore Hip Prosthesis Fenestrated Stem Ref K874616

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

  • Hi-Nek Total Hip Ref K873632

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

  • Bovac Smoke Collector Ref K884641

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

  • Fixator Pin (External) Ref K881511

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

  • Splinh, Forearm Ref K770891

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

  • Icu/Cpu Transport Tray Ref K864878

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

  • Pivoting Surgical Arm Boards Ref K870099

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

  • Lithotomy Holders Ref K870098

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

  • Free Flex Heel Height Adjustor Ref K823396

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

  • Upper Extremity Traction Device Ref K803021

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

  • Corin Bipolar Prosthesis Ref K881289

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

  • Splint, Cockup Ref K770890

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

  • Orthopedic Soft Goods Ref K771109

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

  • Anchors Away Soft Tissue Attachment System Ref K952495

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

  • Arthroscopic Meniscal Suture System Ref K871323

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

  • Hand Surgery Table Extension Ref K871225

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

  • Asst-3000 Spinal Surgery Table Ref K883457

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

  • Stax Finger Splints Ref K823393

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

  • Cruciometer Ref K884483

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

  • Cancellous Screw Ref K862990

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

  • Freeman Total Hip System Titanium Modular System Ref K873626

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

  • Cti Ii Straight Stem Ref K891539

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

  • Plaster Stand Ref K870100

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

  • Positive Closure Anesthetic Valve Ref K811015

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

  • Cancellous Screw Short Thread Diameter 6.5mm Ref K895218

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

  • Andrews Remote Chuck Drill Ref K831043

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

  • Forearm Reduction Unit Ref K823392

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

  • Lamoreux-Osi Electrogoniometer Ref K831040

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

  • Cohn Targeteer Ref K891903

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

  • Isokinetic System, Testing And Evaluation Ref K875235

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

  • Collins Positioning Device Ref K864880

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

  • Herman Cannula Set Ref K880203

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

  • Silicone Plug Ref K896678

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

  • Octagonal Aluminum Framing System Ref K790729

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

  • Cortical Screw Ref K895217

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

  • Spine Motion Analyzer With Emg Ref K920256

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

  • Chemonucleolysis Table Extension Ref K831042

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

  • Cover Limb Ref K823399

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

  • Cti Straight Stem Ref K873627

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

Rows 1-50 of 90

Showing 1-50 of 90

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2007

    • 14 Feb 2007 Z-0780-2007 Unclassified (pre-2012) Terminated Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue. Distribution: The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.

Frequently asked questions

How many devices does Orthopedic Systems, Inc. have in the registry?

The registry currently lists 90 devices for Orthopedic Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orthopedic Systems, Inc.'s devices?

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

What risk classes do Orthopedic Systems, Inc.'s devices fall under?

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

Are there FDA recall records for Orthopedic Systems, Inc.?

FDA recall records list 1 recall initiated by Orthopedic Systems, Inc., the most recent initiated on 14 Feb 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Orthopedic Systems, Inc. in the registry?

The most recently registered devices listed for Orthopedic Systems, Inc. include BLAKEMORE RETAINER, EXTREMITY ELEVATOR, TENDON LEADER and FREEMAN TOTAL HIP SYSTEM RIDGED STEM.

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