The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for K4 Bone Screw System.
| Device ID | K950704 |
| 510k Number | K950704 |
| Device Name: | K4 BONE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Contact | Mark G Urbanski |
| Correspondent | Mark G Urbanski KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-15 |
| Decision Date | 1995-06-30 |