Data / Medical devices / Bone Grafting Material, Human Source / United States
FDA-registered makers of Bone Grafting Material, Human Source in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Bone Grafting Material, Human Source (product code NUN). 11 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Bone Grafting Material, Human Source
- Product code
- NUN
- Country
- United States
Makers of Bone Grafting Material, Human Source in the United States
| 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 |
| 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 November 2, 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.