Biostructures, LLC
Mission Viejo, CA, US
Biostructures, LLC appears in FDA device records in Mission Viejo, CA. FDA records list 5 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Biostructures, LLC between 2010 and 2016. The busiest year on record is 2010, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160446 | MCP Bone Putty | MQV | Substantially Equivalent | |
| K142276 | MCS Bone Graft | MQV | Substantially Equivalent | |
| K132071 | BIOACTIVE BONE GRAFT PUTTY | MQV | Substantially Equivalent | |
| K112857 | INTERFACE BONE VOID FILLER | MQV | Substantially Equivalent | |
| K092541 | INTERFACE | MQV | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1677-2011 | OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use. | The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain