The following data is part of a premarket notification filed by Thompson Mis Inc with the FDA for Bonebac T-plif Intervertebral Body Fusion Device System.
| Device ID | K111512 |
| 510k Number | K111512 |
| Device Name: | BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | THOMPSON MIS INC 45 STILES RD SUITE 210 Salem, NH 03079 |
| Contact | Frank Sullivan |
| Correspondent | Frank Sullivan THOMPSON MIS INC 45 STILES RD SUITE 210 Salem, NH 03079 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-01 |
| Decision Date | 2011-10-26 |
| Summary: | summary |