Data / Medical devices / Bone Grafting Material, Human Source
Bone Grafting Material, Human Source (NUN): 14 FDA-registered makers in 2 countries
14 establishments in 2 countries are registered with the FDA to make Bone Grafting Material, Human Source (product code NUN, Class 2, 21 CFR 872.3930). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on January 10, 2014, and lists 0 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
- NUN
- Device class
- 2
- Regulation
- 872.3930
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| South Korea | 1 |
Makers of Bone Grafting Material, Human 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 |
|---|---|---|---|---|---|---|---|---|
| Keystone Dental Inc. | Irvine, CA, United States | Manufacturer | 3 | March 29, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 2 | January 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Osteotech, Inc. | Eatontown, NJ, United States | Manufacturer | 2 | January 3, 2006 | 0 | 0 | 0 | api.fda.gov |
| Salvin Dental Specialties, LLC | Charlotte, NC, United States | Repackager or relabeler, Specification developer | 2 | August 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| ZimVie US Corp LLC | Palm Beach Gardens, FL, United States | Specification developer | 2 | January 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Exactech, Inc. | Gainesville, FL, United States | Manufacturer | 1 | August 12, 2011 | 0 | 0 | 0 | api.fda.gov |
| Hans Biomed Corp. | Daejeon, South Korea | Manufacturer | 1 | January 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Contract manufacturer, Manufacturer | 1 | March 29, 2006 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Olyphant, PA, United States | Manufacturer | 1 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Edison, NJ, United States | Manufacturer | 1 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics | Jessup, PA, United States | Manufacturer | 1 | April 29, 2005 | 0 | 0 | 0 | api.fda.gov |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | Alachua, FL, United States | Manufacturer | 1 | April 30, 2008 | 0 | 0 | 0 | api.fda.gov |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics Radiation Technologies, LLC | San Diego, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 10, 2014. 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.