The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Neuropro Low Profile Cranial Plating System.
| Device ID | K122049 |
| 510k Number | K122049 |
| Device Name: | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| Contact | Heather Neely |
| Correspondent | Heather Neely KINAMED, INC. 820 FLYNN RD. Camarillo, CA 93012 |
| 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 | 2012-07-12 |
| Decision Date | 2013-04-05 |
| Summary: | summary |