The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kompressor Screw System.
| Device ID | K024233 |
| 510k Number | K024233 |
| Device Name: | KOMPRESSOR SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD. Carlsbad, CA 92009 |
| Contact | John G Spampinato |
| Correspondent | John G Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD. Carlsbad, CA 92009 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-02-06 |
| Summary: | summary |