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 |