Panels › Orthopedic › Product code HST · Class 1
Apparatus, Traction, Non-Powered
Regulation 888.5850
0510(k)s in 12 months (38 all time)
0recalls in 12 months (11 all time)
1recalls that name a 510(k)
Top companies in HST
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthopedic Systems, Inc. | 8 | 0 |
| Allen Medical Systems, Inc. | 0 | 3 |
| Lossing Orthopedic, Inc. | 3 | 0 |
| Biomet, Inc. | 2 | 0 |
| Comfortex, Inc. | 2 | 0 |
| Acufex Microsurgical, Inc. | 1 | 0 |
| American Health Tech., Inc. | 1 | 0 |
| Back-On-Track, Inc. | 1 | 0 |
| Ballert Orthopedic Corp. | 1 | 0 |
| Baxter Healthcare Corporation | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2024 | Baxter Healthcare Corporation HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery Open, Classified |
HST | None listed |
| Feb 14, 2017 | Allen Medical Systems, Inc. Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01
Product Usage:
The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shou Terminated |
HST | None listed |
| Nov 23, 2016 | Allen Medical Systems, Inc. Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016. Terminated |
HST | None listed |
| Jan 20, 2015 | Dick's Sporting Goods Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wellness, Inc. (in user manuals); The products are inversion ta Terminated |
HST | None listed |
| Feb 20, 2014 | Implantech Associates Inc Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766.
Product Usage:
To be used where limb support and/or elevation is considered necessary. Terminated |
HST | None listed |
| Jul 22, 2013 | Steris Corporation STERIS Fine Traction Device, one unit per box
Product Usage:
The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic Terminated |
HST | None listed |
| Jun 14, 2013 | Zimmer, Inc. Zimmer Patient Helper Bed Frame Adapter Assembly
The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient help Terminated |
HST | None listed |
| Mar 18, 2013 | Allen Medical Systems, Inc. Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinic Terminated |
HST | None listed |
| May 14, 2010 | Stryker Endoscopy Stryker Endoscopy PrepStrap Shoulder Sleeve, Model Number 3910900200, Manufactured by Stryker Endoscopy, San Jose, CA Terminated |
HST | None listed |
| Oct 21, 2009 | Linvatec Corp. dba ConMed Linvatec Arthro-Knife, ConMed, Linvatec 11311 Concept Blvd, Largo FL 33773, Made in USA. RX only. U.S. PAT NO. 5.141.517.
The Arthro-Knife is a one piece disposable assembly comprised of a plastic handle wit Terminated |
HST | None listed |
| Aug 31, 2005 | Sammons Preston Rolyan, An Ability One Company TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., Terminated |
HST | K992545 |
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