The following data is part of a premarket notification filed by Biostructures, Llc with the FDA for Interface Bone Void Filler.
| Device ID | K112857 |
| 510k Number | K112857 |
| Device Name: | INTERFACE BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOSTRUCTURES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Kevin A Thomas |
| Correspondent | Kevin A Thomas BIOSTRUCTURES, LLC 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2011-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816986020037 | K112857 | 000 |