The following data is part of a premarket notification filed by Biostructures, Llc with the FDA for Bioactive Bone Graft Putty.
| Device ID | K132071 |
| 510k Number | K132071 |
| Device Name: | BIOACTIVE BONE GRAFT PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOSTRUCTURES, LLC 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler, Jd, Rac |
| Correspondent | Patsy J Trisler, Jd, Rac BIOSTRUCTURES, LLC 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816986020082 | K132071 | 000 |
| 00816986020020 | K132071 | 000 |
| 00816986020013 | K132071 | 000 |
| 00816986020006 | K132071 | 000 |
| 00816986020150 | K132071 | 000 |
| 00816986020143 | K132071 | 000 |
| 00816986020136 | K132071 | 000 |
| 00816986020105 | K132071 | 000 |
| 00816986020099 | K132071 | 000 |