The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Distal Tibia Plates.
Device ID | K013248 |
510k Number | K013248 |
Device Name: | SYNTHES LCP DISTAL TIBIA PLATES |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Matthew M Hull |
Correspondent | Matthew M Hull SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-09-28 |
Decision Date | 2001-12-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67902112523S0 | K013248 | 000 |
H67902112511S0 | K013248 | 000 |
H679021125110 | K013248 | 000 |
H67902112510S0 | K013248 | 000 |
H679021125100 | K013248 | 000 |
H6792399200 | K013248 | 000 |
H6792399000 | K013248 | 000 |
H679041125310 | K013248 | 000 |
H679041125300 | K013248 | 000 |
H679021125140 | K013248 | 000 |
H67902112514S0 | K013248 | 000 |
H679021125150 | K013248 | 000 |
H679021125230 | K013248 | 000 |
H67902112522S0 | K013248 | 000 |
H679021125220 | K013248 | 000 |
H67902112519S0 | K013248 | 000 |
H679021125190 | K013248 | 000 |
H67902112518S0 | K013248 | 000 |
H679021125180 | K013248 | 000 |
H67902112515S0 | K013248 | 000 |
H679041125270 | K013248 | 000 |
H679041125260 | K013248 | 000 |
H6792387080 | K013248 | 000 |
H6792387070 | K013248 | 000 |
H6792387060 | K013248 | 000 |
H6792387050 | K013248 | 000 |
H6792387040 | K013248 | 000 |
H6792387030 | K013248 | 000 |
H6792387020 | K013248 | 000 |
H6792387010 | K013248 | 000 |
H6792387090 | K013248 | 000 |
H6792387100 | K013248 | 000 |
H6792387110 | K013248 | 000 |
H679041125230 | K013248 | 000 |
H679041125220 | K013248 | 000 |
H679041125190 | K013248 | 000 |
H679041125180 | K013248 | 000 |
H679041125150 | K013248 | 000 |
H679041125140 | K013248 | 000 |
H679041125110 | K013248 | 000 |
H679041125100 | K013248 | 000 |
H6792387000 | K013248 | 000 |
H679238711S0 | K013248 | 000 |
H679239921S0 | K013248 | 000 |
H679239920S0 | K013248 | 000 |
H679239917S0 | K013248 | 000 |
H679239916S0 | K013248 | 000 |
H679239913S0 | K013248 | 000 |
H679239912S0 | K013248 | 000 |
H679239909S0 | K013248 | 000 |
H679239908S0 | K013248 | 000 |
H679238700S0 | K013248 | 000 |
H679238701S0 | K013248 | 000 |
H679238702S0 | K013248 | 000 |
H679238710S0 | K013248 | 000 |
H679238709S0 | K013248 | 000 |
H679238708S0 | K013248 | 000 |
H679238707S0 | K013248 | 000 |
H679238706S0 | K013248 | 000 |
H679238705S0 | K013248 | 000 |
H679238704S0 | K013248 | 000 |
H679238703S0 | K013248 | 000 |
H679239905S0 | K013248 | 000 |
H679239904S0 | K013248 | 000 |
H6792399010 | K013248 | 000 |
H67902112531S0 | K013248 | 000 |
H679021125310 | K013248 | 000 |
H67902112530S0 | K013248 | 000 |
H679021125300 | K013248 | 000 |
H67902112527S0 | K013248 | 000 |
H679021125270 | K013248 | 000 |
H67902112526S0 | K013248 | 000 |
H6792399040 | K013248 | 000 |
H6792399050 | K013248 | 000 |
H6792399080 | K013248 | 000 |
H679239901S0 | K013248 | 000 |
H679239900S0 | K013248 | 000 |
H6792399210 | K013248 | 000 |
H6792399170 | K013248 | 000 |
H6792399160 | K013248 | 000 |
H6792399130 | K013248 | 000 |
H6792399120 | K013248 | 000 |
H6792399090 | K013248 | 000 |
H679021125260 | K013248 | 000 |