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
| Country | Makers |
|---|---|
| United States | 25 |
| South Korea | 5 |
| Germany | 4 |
| France | 4 |
| Switzerland | 4 |
| United Kingdom | 3 |
| Finland | 3 |
| Israel | 2 |
| Japan | 1 |
| Netherlands | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer, Specification developer | 4 | September 27, 2013 | 0 | 0 | 0 | api.fda.gov |
| Curasan AG | KLEINOSTHEIM Bavaria, Germany | Specification developer | 4 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Curasan AG, Frankfurt Facility | FRANKFURT Hesse, Germany | Manufacturer | 4 | December 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Manufacturer, Manufacturer for export, Specification developer | 4 | September 27, 2013 | 0 | 1 | 0 | api.fda.gov |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 4 | May 25, 2010 | 0 | 0 | 0 | api.fda.gov |
| GENOSS Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 4 | September 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Steiner Biotechnology | Henderson, NV, United States | Manufacturer | 4 | January 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Advanced Medical Solutions (Nantes) SAS | VIGNEUX DE BRETAGNE Loire-Atlantique, France | Manufacturer | 3 | March 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| GC America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 3 | August 17, 2020 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Complaint file establishment, Manufacturer | 3 | July 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 3 | June 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Novabone Products, LLC | Alachua, FL, United States | Manufacturer | 3 | December 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Unicare Biomedical, Inc. | Laguna Hills, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | November 25, 2009 | 0 | 0 | 0 | api.fda.gov |
| Augma Biomaterials | Caesarea Southern Industrial Park Northern, Israel | Manufacturer | 2 | December 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 2 | March 28, 1995 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer | 2 | July 26, 1999 | 0 | 1 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 2 | July 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Specification developer | 2 | July 26, 1999 | 0 | 0 | 0 | api.fda.gov |
| Keystone Dental Inc. | Irvine, CA, United States | Manufacturer | 2 | February 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Osteogenics Biomedical, Inc. | Lubbock, TX, United States | Manufacturer | 2 | August 6, 1997 | 0 | 1 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 2 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Apatech Ltd. | ELSTREE Hertfordshire, United Kingdom | Manufacturer | 1 | July 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Bicon, LLC | Boston, MA, United States | Specification developer | 1 | September 1, 2005 | 0 | 0 | 0 | api.fda.gov |
| Bonalive Ltd | Turku Varsinais-Suomi, Finland | Manufacturer | 1 | May 14, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ceramisys Ltd | Sheffield York, United Kingdom | Manufacturer | 1 | November 3, 2011 | 0 | 0 | 0 | api.fda.gov |
| CG Bio Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | May 19, 2009 | 0 | 0 | 0 | api.fda.gov |
| Cytophil, Inc | East Troy, WI, United States | Manufacturer | 1 | April 22, 2010 | 0 | 1 | 0 | api.fda.gov |
| Depuy CMW | Blackpool, Lancashire, United Kingdom | Manufacturer | 1 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Contract manufacturer, Manufacturer | 1 | October 15, 1996 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 1 | July 3, 2001 | 0 | 0 | 0 | api.fda.gov |
| Hudens Bio Co., Ltd. | Gwangju, South Korea | Manufacturer | 1 | March 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Impladent, Ltd. | Northborough, MA, United States | Manufacturer, Specification developer | 1 | April 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Inion OY | TAMPERE Pirkanmaa, Finland | Manufacturer | 1 | July 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Complaint file establishment, Specification developer | 1 | September 24, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 1 | January 18, 2001 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Deggendorf GMBH | DEGGENDORF Bavaria, Germany | Manufacturer | 1 | January 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Meta Biomed Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 1 | June 3, 2008 | 0 | 0 | 0 | api.fda.gov |
| MIS Implants Technologies Ltd. | BAR LEV INDUSTRIAL PARK Northern, Israel | Contract manufacturer, Exporter to the US | 1 | September 16, 2005 | 0 | 0 | 0 | api.fda.gov |
| Osteogene Tech Corp | Norwood, NJ, United States | Manufacturer | 1 | March 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Septodont | CEDEX Val-de-Marne, France | Manufacturer | 1 | May 11, 2007 | 0 | 0 | 0 | api.fda.gov |
| Soyagreentec Co.,ltd | Hwaseong-si Gyeonggi, South Korea | Contract sterilizer, Manufacturer | 1 | April 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Specification developer | 1 | September 27, 2010 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| SYNTHES GMBH / Synthes Produktions GmbH | Oberdorf, Baselland Basel-Landschaft, Switzerland | Manufacturer | 1 | January 23, 2006 | 0 | 0 | 0 | api.fda.gov |
| Teknimed SAS | L Union Haute-Garonne, France | Complaint file establishment, Manufacturer | 1 | March 4, 2009 | 0 | 0 | 0 | api.fda.gov |
| Arctic Biomaterials OY | Tampere Pirkanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BBF Sterilisationsservice GMBH | Kernen Baden-Wurttemberg, Germany | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet France | Valence Drome, France | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cam Bioceramics | LEIDEN Zuid-Holland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contech Medical, Inc. | Providence, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GFS Chemicals, Inc. | Columbus, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.