The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for C-box Peek Cervical Ibf.
| Device ID | K132991 |
| 510k Number | K132991 |
| Device Name: | C-BOX PEEK CERVICAL IBF |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-24 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M71112512130 | K132991 | 000 |
| M71112511130 | K132991 | 000 |
| M71112510130 | K132991 | 000 |
| M71112509130 | K132991 | 000 |
| M71112508130 | K132991 | 000 |
| M71112507130 | K132991 | 000 |
| M71112506130 | K132991 | 000 |