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Data / Medical devices / Spinal Channeling Instrument, Vertebroplasty

Spinal Channeling Instrument, Vertebroplasty (OCJ): 31 FDA-registered makers in 9 countries

31 establishments in 9 countries are registered with the FDA to make Spinal Channeling Instrument, Vertebroplasty (product code OCJ, Class 1, 21 CFR 888.4540). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 10, 2007, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
OCJ
Device class
1
Regulation
888.4540
Medical specialty
Orthopedic

Makers by country

CountryMakers
United States11
China5
Italy4
India3
South Korea3
France2
Pakistan1
Taiwan1
Switzerland1

Makers of Spinal Channeling Instrument, Vertebroplasty

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
Izi Medical Products LLCOwings Mills, MD, United StatesManufacturer1July 10, 2007000api.fda.gov
Adria SRL.San Giovanni in Persiceto Bologna, ItalyManufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Auxein medical Private limitedSonipat Haryana, IndiaManufacturer0000api.fda.gov
Beijing Fule Science & Technology Development Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Biopsybell S.R.L.MIRANDOLA Modena, ItalyManufacturer0000api.fda.gov
Degen MedicalFlorence, SC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.Sialkot Punjab, PakistanManufacturer0000api.fda.gov
G21 S.R.I.San Possidonio Modena, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
Gesco Healthcare Private LimitedCHENNAI, Tamil Nadu, IndiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hicren (Zhejiang) Medtech Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Imedicom Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Jiangsu Changmei Medtech Co.,ltdChangzhou Jiangsu, ChinaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
Miing Wei Co., Ltd.Tsao-Twon Nantou, TaiwanContract manufacturer0000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Shanghai Lange Medtech Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Medical Instruments (group) Ltd. Corp.Shanghai, ChinaManufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Taeyeon Medical Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer0000api.fda.gov
Tecres SPAVERONA Veneto, ItalyExporter to the US, Manufacturer0000api.fda.gov
Teknimed SASL Union Haute-Garonne, FranceComplaint file establishment, Manufacturer0000api.fda.gov
Thiebaud SASParis Ile-de-France, FranceComplaint file establishment, Contract sterilizer, Manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov

Updated July 10, 2007. 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.