The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Accell Evo3c.
| Device ID | K091193 |
| 510k Number | K091193 |
| Device Name: | ACCELL EVO3C |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE A Irvine, CA 92618 |
| Contact | Carroll Councilman |
| Correspondent | Carroll Councilman ISOTIS ORTHOBIOLOGICS, INC 2 GOODYEAR, SUITE A Irvine, CA 92618 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M386565101001 | K091193 | 000 |
| M386565100501 | K091193 | 000 |
| M386565100251 | K091193 | 000 |
| M3860260001001 | K091193 | 000 |
| M3860260000501 | K091193 | 000 |
| M3860260000251 | K091193 | 000 |
| 10381780112594 | K091193 | 000 |
| 10381780112587 | K091193 | 000 |
| M386XPRES3C101 | K091193 | 000 |