The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Resorb-x Resorbable Plating System.
Device ID | K011590 |
510k Number | K011590 |
Device Name: | RESORB-X RESORBABLE PLATING SYSTEM |
Classification | Plate, Bone |
Applicant | KLS-MARTIN L.P. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
Contact | Arthur Ward |
Correspondent | Arthur Ward KLS-MARTIN L.P. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-23 |
Decision Date | 2002-03-20 |
Summary: | summary |