The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Fortross Bone Void Filler.
| Device ID | K110561 |
| 510k Number | K110561 |
| Device Name: | FORTROSS BONE VOID FILLER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | PIONEER SURGICAL TECHNOLOGY 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | David J Collette |
| Correspondent | David J Collette PIONEER SURGICAL TECHNOLOGY 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2011-04-29 |
| Summary: | summary |