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Data / Medical devices / Cement, Bone, Vertebroplasty / United States

FDA-registered makers of Cement, Bone, Vertebroplasty in the United States: 24 establishments

24 establishments in the United States are registered with the FDA to make Cement, Bone, Vertebroplasty (product code NDN). 14 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Cement, Bone, Vertebroplasty
Product code
NDN
Country
United States

Makers of Cement, Bone, Vertebroplasty in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer6April 9, 2015000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer6December 20, 2022000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer, Manufacturer for export5January 23, 2017000api.fda.gov
Izi Medical Products LLCOwings Mills, MD, United StatesComplaint file establishment, Manufacturer, Specification developer5August 14, 2014000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer4November 21, 2007030api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer4April 18, 2022000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer4April 18, 2022000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer4November 1, 2016010api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2January 23, 2017000api.fda.gov
HypreventionNew York, NY, United StatesManufacturer2February 9, 2024000api.fda.gov
BONWRx LtdLansing, MI, United StatesComplaint file establishment, Manufacturer, Manufacturer for export1November 8, 2019000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1November 8, 2005000api.fda.gov
Penn United Technologies, Inc.Warminster, PA, United StatesManufacturer1October 25, 2011000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1April 3, 2013000api.fda.gov
J & J Precision Technologies, LLCLititz, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Kimball Solutions - IndianapolisIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer0000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer0000api.fda.gov
Midwest Interventional SystemsMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCSalt Lake City, UT, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Sterigenics U.S., LLCCorona, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer0000api.fda.gov

Updated November 2, 2026. 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.