Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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

Makers by country

CountryMakers
United States9
South Korea6
Switzerland2
Germany2
Argentina1
Belgium1
New Zealand1
Taiwan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Collagen Matrix, Inc.Oakland, NJ, United StatesSpecification developer7April 2, 2021010api.fda.gov
Collagen Matrix, IncAllendale, NJ, United StatesManufacturer7April 2, 2021030api.fda.gov
Geistlich Pharma AGWOLHUSEN Luzern, SwitzerlandComplaint file establishment, Manufacturer5July 11, 2025000api.fda.gov
Nibec Co LtdJincheon-gun Chungbuk, South KoreaContract manufacturer, Manufacturer4December 10, 2015000api.fda.gov
Purgo Biologics Inc.Seongnam-si Gyeonggi, South KoreaManufacturer3July 24, 2024000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesManufacturer2September 10, 2020000api.fda.gov
Medpark Co., Ltd.Busan, South KoreaManufacturer2June 16, 2026000api.fda.gov
Sigmagraft, Inc.Fullerton, CA, United StatesManufacturer2March 18, 2023000api.fda.gov
Botiss Biomaterials GMBHZossen Brandenburg, GermanyComplaint file establishment, Exporter to the US, Specification developer1October 19, 2018000api.fda.gov
Chiyewon Co., Ltd.Guri-si Gyeonggi, South KoreaManufacturer1June 5, 2015000api.fda.gov
COLLAGEN SOLUTIONS/TISSX LLC d/b/a EvergenEden Prairie, MN, United StatesSpecification developer1August 16, 2024000api.fda.gov
Hiossen Inc.Fairless Hills, PA, United StatesManufacturer1August 3, 2016000api.fda.gov
Impladent, Ltd.Northborough, MA, United StatesSpecification developer1December 10, 2009000api.fda.gov
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandSpecification developer1January 16, 2013000api.fda.gov
Odontit SABUENOS AIRES Buenos Aires, Ciudad Autonoma de, ArgentinaContract manufacturer, Manufacturer1May 22, 2014000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer1August 3, 2016000api.fda.gov
WishboneFlemalle Liege, BelgiumManufacturer1August 20, 2021000api.fda.gov
Aroa Biosurgery LtdAirport Oaks Auckland, New ZealandComplaint file establishment, Manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Maxigen Biotech, Inc.Taoyuan City, TaiwanContract manufacturer0000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer0000api.fda.gov
Meta Biomed Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov
mebios GmbHDieburg Hesse, GermanyContract manufacturer0000api.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.