Data / Medical devices / Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation (OIS): 8 FDA-registered makers in 2 countries
8 establishments in 2 countries are registered with the FDA to make Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation (product code OIS, Class 2, 21 CFR 888.3045). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 2, 2008, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OIS
- Device class
- 2
- Regulation
- 888.3045
- Medical specialty
- Orthopedic
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Switzerland | 1 |
Makers of Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
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 |
|---|---|---|---|---|---|---|---|---|
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 1 | July 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 1 | July 2, 2008 | 0 | 1 | 0 | api.fda.gov |
| Abyrx, Inc. | Stamford, CT, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bone Solutions, Inc. | Colleyville, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DSM Biomedical, Inc. | Exton, PA, United States | 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 | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 2, 2008. 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.