The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. with the FDA for Nb3d Bone Void Filler.
| Device ID | K111944 |
| 510k Number | K111944 |
| Device Name: | NB3D BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PIONEER SURGICAL TECHNOLOGY, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson PIONEER SURGICAL TECHNOLOGY, INC. 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 | 2011-07-08 |
| Decision Date | 2011-11-22 |
| Summary: | summary |