The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin Drill-free Mmf Screw.
Device ID | K042573 |
510k Number | K042573 |
Device Name: | KLS MARTIN DRILL-FREE MMF SCREW |
Classification | Screw, Fixation, Intraosseous |
Applicant | KLS-MARTIN L.P. 1239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
Contact | Jennifer Damato |
Correspondent | Jennifer Damato KLS-MARTIN L.P. 1239-1 ST. JOHN'S IND. PKWY. 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 | 2004-09-21 |
Decision Date | 2004-10-18 |
Summary: | summary |