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Data / Medical devices / Bone Grafting Material, Synthetic / United States

FDA-registered makers of Bone Grafting Material, Synthetic in the United States: 25 establishments

25 establishments in the United States are registered with the FDA to make Bone Grafting Material, Synthetic (product code LYC). 22 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device
Bone Grafting Material, Synthetic
Product code
LYC
Country
United States

Makers of Bone Grafting Material, Synthetic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Collagen Matrix, Inc.Oakland, NJ, United StatesManufacturer, Specification developer4September 27, 2013000api.fda.gov
Collagen Matrix, IncAllendale, NJ, United StatesManufacturer, Manufacturer for export, Specification developer4September 27, 2013010api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer4May 25, 2010000api.fda.gov
Steiner BiotechnologyHenderson, NV, United StatesManufacturer4January 27, 2012000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3August 17, 2020000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer3June 10, 2014000api.fda.gov
Novabone Products, LLCAlachua, FL, United StatesManufacturer3December 16, 2011000api.fda.gov
Unicare Biomedical, Inc.Laguna Hills, CA, United StatesManufacturer, Repackager or relabeler, Specification developer3November 25, 2009000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer2March 28, 1995000api.fda.gov
Integra Lifesciences CorporationPlainsboro, NJ, United StatesManufacturer2July 26, 1999010api.fda.gov
Integra NeurosciencesAnasco, PR, United StatesManufacturer2July 26, 1999000api.fda.gov
Integra LifeSciences CorporationPrinceton, NJ, United StatesComplaint file establishment, Specification developer2July 26, 1999000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer2February 14, 2005000api.fda.gov
Osteogenics Biomedical, Inc.Lubbock, TX, United StatesManufacturer2August 6, 1997010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer2January 23, 2006000api.fda.gov
Bicon, LLCBoston, MA, United StatesSpecification developer1September 1, 2005000api.fda.gov
Cytophil, IncEast Troy, WI, United StatesManufacturer1April 22, 2010010api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer, Manufacturer1October 15, 1996000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer1July 3, 2001000api.fda.gov
Impladent, Ltd.Northborough, MA, United StatesManufacturer, Specification developer1April 27, 2004000api.fda.gov
Osteogene Tech CorpNorwood, NJ, United StatesManufacturer1March 4, 2022000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Specification developer1September 27, 2010000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
GFS Chemicals, Inc.Columbus, OH, United StatesContract manufacturer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.