The following data is part of a premarket notification filed by Isotis Orthobiologics, Inc with the FDA for Accell Tbm-r.
| Device ID | K081817 |
| 510k Number | K081817 |
| Device Name: | ACCELL TBM-R |
| Classification | Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) |
| Applicant | ISOTIS ORTHOBIOLOGICS, INC 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady ISOTIS ORTHOBIOLOGICS, INC 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | MBP |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-09-24 |
| Summary: | summary |