The following data is part of a premarket notification filed by Integra Lifesciences with the FDA for Accell Evo3 (formerly Accell A2i).
| Device ID | K103742 |
| 510k Number | K103742 |
| Device Name: | ACCELL EVO3 (FORMERLY ACCELL A2I) |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | INTEGRA LIFESCIENCES 2 GOODYEAR Irvine, CA 92672 |
| Contact | Jenny Fam |
| Correspondent | Jenny Fam INTEGRA LIFESCIENCES 2 GOODYEAR Irvine, CA 92672 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-03-17 |
| Summary: | summary |