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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711C5SS190040 | K141644 | 000 |
| M711BTA990 | K141644 | 000 |
| M711C2BR161550 | K141644 | 000 |
| M711C2BR161560 | K141644 | 000 |
| M711C2BR162250 | K141644 | 000 |
| M711C2BR162260 | K141644 | 000 |
| M711C2DY160060 | K141644 | 000 |
| M711C2SQ160040 | K141644 | 000 |
| M711C2ST160020 | K141644 | 000 |
| M711C2ST160060 | K141644 | 000 |
| M711C2ST160120 | K141644 | 000 |
| M711C2ST161020 | K141644 | 000 |
| M711C3DM061000 | K141644 | 000 |
| M711C5SD160030 | K141644 | 000 |
| M711C5SD160040 | K141644 | 000 |
| M711C5SD160050 | K141644 | 000 |
| M711BTA1000 | K141644 | 000 |