Data / Medical devices / Bone Grafting Material, Animal Source
Bone Grafting Material, Animal Source (NPM): 23 FDA-registered makers in 8 countries
23 establishments in 8 countries are registered with the FDA to make Bone Grafting Material, Animal Source (product code NPM, Class 2, 21 CFR 872.3930). 17 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 42 510(k) clearances under this code, the latest on October 9, 2026, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NPM
- Device class
- 2
- Regulation
- 872.3930
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| South Korea | 6 |
| Switzerland | 2 |
| Germany | 2 |
| Argentina | 1 |
| Belgium | 1 |
| New Zealand | 1 |
| Taiwan | 1 |
Makers of Bone Grafting Material, Animal Source
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 | Specification developer | 7 | April 2, 2021 | 0 | 1 | 0 | api.fda.gov |
| Collagen Matrix, Inc | Allendale, NJ, United States | Manufacturer | 7 | April 2, 2021 | 0 | 3 | 0 | api.fda.gov |
| Geistlich Pharma AG | WOLHUSEN Luzern, Switzerland | Complaint file establishment, Manufacturer | 5 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nibec Co Ltd | Jincheon-gun Chungbuk, South Korea | Contract manufacturer, Manufacturer | 4 | December 10, 2015 | 0 | 0 | 0 | api.fda.gov |
| Purgo Biologics Inc. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 3 | July 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| DSM Biomedical, Inc. | Exton, PA, United States | Manufacturer | 2 | September 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medpark Co., Ltd. | Busan, South Korea | Manufacturer | 2 | June 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sigmagraft, Inc. | Fullerton, CA, United States | Manufacturer | 2 | March 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Botiss Biomaterials GMBH | Zossen Brandenburg, Germany | Complaint file establishment, Exporter to the US, Specification developer | 1 | October 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Chiyewon Co., Ltd. | Guri-si Gyeonggi, South Korea | Manufacturer | 1 | June 5, 2015 | 0 | 0 | 0 | api.fda.gov |
| COLLAGEN SOLUTIONS/TISSX LLC d/b/a Evergen | Eden Prairie, MN, United States | Specification developer | 1 | August 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hiossen Inc. | Fairless Hills, PA, United States | Manufacturer | 1 | August 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Impladent, Ltd. | Northborough, MA, United States | Specification developer | 1 | December 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Specification developer | 1 | January 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Odontit SA | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | Contract manufacturer, Manufacturer | 1 | May 22, 2014 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 1 | August 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Wishbone | Flemalle Liege, Belgium | Manufacturer | 1 | August 20, 2021 | 0 | 0 | 0 | api.fda.gov |
| Aroa Biosurgery Ltd | Airport Oaks Auckland, New Zealand | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maxigen Biotech, Inc. | Taoyuan City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Meta Biomed Co., Ltd. | Cheongju-si Chungbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| mebios GmbH | Dieburg Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 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.