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Data / Medical devices / Component, Cast

Component, Cast (LGF): 39 FDA-registered makers in 9 countries

39 establishments in 9 countries are registered with the FDA to make Component, Cast (product code LGF, Class 1, 21 CFR 888.5940). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 31 510(k) clearances under this code, the latest on March 10, 2005, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LGF
Device class
1
Regulation
888.5940
Medical specialty
Orthopedic

Makers by country

CountryMakers
China17
United States10
Mexico4
South Korea2
Belgium2
United Kingdom1
India1
Cambodia1
Egypt1

Makers of Component, Cast

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
AlphapointeKansas City, MO, United StatesManufacturer0000api.fda.gov
Anji Fang Yuan Sanitary Material Co., Ltd.ANJI Zhejiang, ChinaManufacturer0000api.fda.gov
Anji Hengfeng Sanitary Material Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anhui Kangfu Industrial Foreign Trade Co.,LtdTianchang Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
BL Tech Co., Ltd.Chuncheon-si Gangwon, South KoreaManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
BSN medical Inc.Charlotte, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Chemtron Biotech, Inc.San Diego, CA, United StatesManufacturer0000api.fda.gov
De Soutter Medical Ltd.ASTON CLINTON Buckinghamshire, United KingdomManufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Elemental Orthopedics LLCMarcola, OR, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Fengtai County Guqiao Town Changxing Shoe FactoryHuainan City Anhui, ChinaContract manufacturer0000api.fda.gov
HANGZHOU TUOPUSI MEDICAL PRODUCTS Co. LtdHangzhou City Zhejiang, ChinaManufacturer0000api.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
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Jiangsu Likang Medical Products Co., Ltd.WUJIANG CITY Jiangsu, ChinaManufacturer0000api.fda.gov
Jiujiang Huada Medical Dressing Co., Ltd.JIUJIANG Jiangxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medstar Healthcare Co.,limitedHuzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Medtecs (cambodia) Corp. LimitedSrok Kampong Siem Kampong Cham, CambodiaContract manufacturer, Exporter to the US0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptExporter to the US, Manufacturer0000api.fda.gov
Orfit Industries NVWIJNEGEM Antwerpen, BelgiumManufacturer0000api.fda.gov
ORTEC Co., LTD.Busan, South KoreaManufacturer0000api.fda.gov
Position Health, LLCLake Forest, IL, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Runlite S.A.SOUMAGNE Liege, BelgiumManufacturer0000api.fda.gov
Shaanxi Ansen Medical Technology Development Co.,ltd.Xi'an Shaanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.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 Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Velcromex, S.A. De C.V.AGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Wear Tex S. De R.L. De C.V.Torreon Coahuila, MexicoContract manufacturer, Exporter to the US0000api.fda.gov
Wheaton Brace CompanyCarol Stream, IL, United StatesSpecification developer0000api.fda.gov
Wuhan Zonsen Medical Products Co., LtdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaManufacturer0000api.fda.gov

Updated March 10, 2005. 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.