The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Profix System.
| Device ID | K964362 |
| 510k Number | K964362 |
| Device Name: | KINAMED PROFIX SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Contact | Robert Bruce |
| Correspondent | Robert Bruce KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-01-16 |