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Data / Medical devices / Splint, Traction

Splint, Traction (HSP): 54 FDA-registered makers in 13 countries

54 establishments in 13 countries are registered with the FDA to make Splint, Traction (product code HSP, Class 1, 21 CFR 888.5890). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 21, 1977, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
HSP
Device class
1
Regulation
888.5890
Medical specialty
Orthopedic

Makers by country

CountryMakers
China23
United States12
India8
Guatemala2
Israel1
Honduras1
Pakistan1
Vietnam1
Singapore1
Mexico1
Germany1
Egypt1
United Kingdom1

Makers of Splint, Traction

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Anji Anshen Surgical Dressings Co., Ltd.Huzhou, Zhejiang, ChinaManufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Anhui Dajiang Medical Products Co.,Ltd.chuzhou Anhui, ChinaManufacturer0000api.fda.gov
Argamon Med LTDGivat Yearim Jerusalem, IsraelManufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Biosculptor CorporationHialeah, FL, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.Maynardville, TN, United StatesContract manufacturer0000api.fda.gov
Dongguan City Risen Medical Products Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Luda Industrial Co., LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Vigor Textile Co.,LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
E.M. Adams De HondurasCHOLOMA Cortes, HondurasManufacturer0000api.fda.gov
Emergency Products & Research, Inc.Kent, OH, United StatesManufacturer0010api.fda.gov
Faretec, Inc.Painesville, OH, United StatesManufacturer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Golden Season Pte LtdSINGAPORE North West, SingaporeContract manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jiangsu Senolo Medical Technology Co., Ltd.Yancheng Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Kentron Health Care, Inc.Springfield, TN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Medicon, E.G.TUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Mizuho Orthopedic Systems, Inc.Union City, CA, United StatesManufacturer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Orihealth Medical Products(suzhou)co.,ltdSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer, Repackager or relabeler0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
Rusun Medical Co., LtdYichun City Jiangxi, ChinaManufacturer0000api.fda.gov
Safeguard Medical Technologies LtdHereford Herefordshire, United KingdomSpecification developer0000api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.Xi'an Shaanxi, ChinaManufacturer0000api.fda.gov
Shandong Haidike Medical Products Co., LtdHeze Shandong, ChinaManufacturer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
SunmedicaRedding, CA, United StatesManufacturer0000api.fda.gov
Suzhou Emy Medical Supplies Co.,ltd.ChangShu Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tri-Tech Forensics, Inc.Leland, NC, United StatesManufacturer, Specification developer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Wheaton Brace CompanyCarol Stream, IL, United StatesSpecification developer0000api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.YIWU Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhangjiagang New Fellow Med Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangjiagang Xiehe Medical Apparatus & Instruments Co., Ltd.ZHANGJIAGANG Jiangsu, ChinaManufacturer0000api.fda.gov

Updated July 21, 1977. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.