The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Kompressor Screw System.
| Device ID | K040356 |
| 510k Number | K040356 |
| Device Name: | KOMPRESSOR SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Contact | John G Spampinato |
| Correspondent | John G Spampinato KINETIKOS MEDICAL, INC. 6005 HIDDEN VALLEY RD, STE 180 Carlsbad, CA 92011 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-13 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2482103261 | K040356 | 000 |
| M2482104261 | K040356 | 000 |
| M2482104241 | K040356 | 000 |
| M2482104221 | K040356 | 000 |
| M2482104201 | K040356 | 000 |
| M2482104181 | K040356 | 000 |
| M2482104161 | K040356 | 000 |
| M2482104141 | K040356 | 000 |
| M2482103181 | K040356 | 000 |
| M2482104281 | K040356 | 000 |
| M2482104301 | K040356 | 000 |
| M2482104321 | K040356 | 000 |
| M2482103241 | K040356 | 000 |
| M2482103221 | K040356 | 000 |
| M2482103201 | K040356 | 000 |
| M2482103161 | K040356 | 000 |
| M2482103141 | K040356 | 000 |
| M2482103121 | K040356 | 000 |
| M2482103101 | K040356 | 000 |
| M2482104341 | K040356 | 000 |
| M248KOMPSET1 | K040356 | 000 |