The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Drill Free Mmf Screw.
| Device ID | K083432 |
| 510k Number | K083432 |
| Device Name: | DRILL FREE MMF SCREW |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Contact | Tom Faucet |
| Correspondent | Tom Faucet KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-20 |
| Decision Date | 2009-03-31 |
| Summary: | summary |