The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Innovasis Cranial System.
| Device ID | K141644 |
| 510k Number | K141644 |
| Device Name: | INNOVASIS CRANIAL SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-19 |
| Decision Date | 2014-11-07 |
| Summary: | summary |