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Data / Medical devices / Bone Grafting Material, Synthetic

Bone Grafting Material, Synthetic (LYC): 52 FDA-registered makers in 10 countries

52 establishments in 10 countries are registered with the FDA to make Bone Grafting Material, Synthetic (product code LYC, Class 2, 21 CFR 872.3930). 45 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 231 510(k) clearances under this code, the latest on July 6, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LYC
Device class
2
Regulation
872.3930
Medical specialty
Dental
Implant
Yes

Makers by country

CountryMakers
United States25
South Korea5
Germany4
France4
Switzerland4
United Kingdom3
Finland3
Israel2
Japan1
Netherlands1

Makers of Bone Grafting Material, Synthetic

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
Collagen Matrix, Inc.Oakland, NJ, United StatesManufacturer, Specification developer4September 27, 2013000api.fda.gov
Curasan AGKLEINOSTHEIM Bavaria, GermanySpecification developer4December 20, 2012000api.fda.gov
Curasan AG, Frankfurt FacilityFRANKFURT Hesse, GermanyManufacturer4December 20, 2012000api.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
GENOSS Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer4September 14, 2016000api.fda.gov
Steiner BiotechnologyHenderson, NV, United StatesManufacturer4January 27, 2012000api.fda.gov
Advanced Medical Solutions (Nantes) SASVIGNEUX DE BRETAGNE Loire-Atlantique, FranceManufacturer3March 15, 2010000api.fda.gov
GC America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3August 17, 2020000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanComplaint file establishment, Manufacturer3July 6, 2026000api.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
Augma BiomaterialsCaesarea Southern Industrial Park Northern, IsraelManufacturer2December 5, 2013000api.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
Apatech Ltd.ELSTREE Hertfordshire, United KingdomManufacturer1July 30, 2009000api.fda.gov
Bicon, LLCBoston, MA, United StatesSpecification developer1September 1, 2005000api.fda.gov
Bonalive LtdTurku Varsinais-Suomi, FinlandManufacturer1May 14, 2026000api.fda.gov
Ceramisys LtdSheffield York, United KingdomManufacturer1November 3, 2011000api.fda.gov
CG Bio Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1May 19, 2009000api.fda.gov
Cytophil, IncEast Troy, WI, United StatesManufacturer1April 22, 2010010api.fda.gov
Depuy CMWBlackpool, Lancashire, United KingdomManufacturer1January 23, 2006000api.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
Hudens Bio Co., Ltd.Gwangju, South KoreaManufacturer1March 6, 2026000api.fda.gov
Impladent, Ltd.Northborough, MA, United StatesManufacturer, Specification developer1April 27, 2004000api.fda.gov
Inion OYTAMPERE Pirkanmaa, FinlandManufacturer1July 24, 2007000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandComplaint file establishment, Specification developer1September 24, 2020000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1January 18, 2001000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer1January 9, 2009000api.fda.gov
Meta Biomed Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer1June 3, 2008000api.fda.gov
MIS Implants Technologies Ltd.BAR LEV INDUSTRIAL PARK Northern, IsraelContract manufacturer, Exporter to the US1September 16, 2005000api.fda.gov
Osteogene Tech CorpNorwood, NJ, United StatesManufacturer1March 4, 2022000api.fda.gov
SeptodontCEDEX Val-de-Marne, FranceManufacturer1May 11, 2007000api.fda.gov
Soyagreentec Co.,ltdHwaseong-si Gyeonggi, South KoreaContract sterilizer, Manufacturer1April 24, 2007000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Specification developer1September 27, 2010000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer1January 23, 2006000api.fda.gov
SYNTHES GMBH / Synthes Produktions GmbHOberdorf, Baselland Basel-Landschaft, SwitzerlandManufacturer1January 23, 2006000api.fda.gov
Teknimed SASL Union Haute-Garonne, FranceComplaint file establishment, Manufacturer1March 4, 2009000api.fda.gov
Arctic Biomaterials OYTampere Pirkanmaa, FinlandContract manufacturer0000api.fda.gov
BBF Sterilisationsservice GMBHKernen Baden-Wurttemberg, GermanyContract manufacturer, Contract sterilizer0000api.fda.gov
Biomet FranceValence Drome, FranceContract manufacturer0010api.fda.gov
Cam BioceramicsLEIDEN Zuid-Holland, NetherlandsContract manufacturer0000api.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 July 6, 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.