The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Locking Distal Radius Plating System.
| Device ID | K012114 |
| 510k Number | K012114 |
| Device Name: | SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM |
| 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 | 2001-07-06 |
| Decision Date | 2001-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982261564 | K012114 | 000 |
| H6794425030 | K012114 | 000 |
| H6794425020 | K012114 | 000 |
| H6794425010 | K012114 | 000 |
| H6794425000 | K012114 | 000 |
| H6794424940 | K012114 | 000 |
| H6794424930 | K012114 | 000 |
| H6794424920 | K012114 | 000 |
| H6794424910 | K012114 | 000 |
| H6794424900 | K012114 | 000 |
| H6794425040 | K012114 | 000 |
| H6794425050 | K012114 | 000 |
| H6794425060 | K012114 | 000 |
| 10886982261557 | K012114 | 000 |
| 10886982261540 | K012114 | 000 |
| 10886982261533 | K012114 | 000 |
| 10886982261526 | K012114 | 000 |
| H6794425120 | K012114 | 000 |
| H6794425110 | K012114 | 000 |
| H6794425090 | K012114 | 000 |
| H6794425080 | K012114 | 000 |
| H6794425070 | K012114 | 000 |
| H6794424790 | K012114 | 000 |
| H6794424780 | K012114 | 000 |
| H6794001990 | K012114 | 000 |
| H6794001980 | K012114 | 000 |
| H6794001970 | K012114 | 000 |
| H6794001960 | K012114 | 000 |
| H6794001950 | K012114 | 000 |
| H6794001940 | K012114 | 000 |
| H6794001930 | K012114 | 000 |
| H6794001920 | K012114 | 000 |
| H6794001910 | K012114 | 000 |
| H6794128060 | K012114 | 000 |
| H6794128080 | K012114 | 000 |
| H6794128100 | K012114 | 000 |
| H6794424770 | K012114 | 000 |
| H6794128280 | K012114 | 000 |
| H6794128260 | K012114 | 000 |
| H6794128240 | K012114 | 000 |
| H6794128220 | K012114 | 000 |
| H6794128180 | K012114 | 000 |
| H6794128160 | K012114 | 000 |
| H6794128140 | K012114 | 000 |
| H6794128120 | K012114 | 000 |
| H6794001900 | K012114 | 000 |
| 10886982261571 | K012114 | 000 |
| H6794128300 | K012114 | 000 |
| H6792424920 | K012114 | 000 |
| H6792424910 | K012114 | 000 |
| H6792424900 | K012114 | 000 |
| H6792424790 | K012114 | 000 |
| H6792424780 | K012114 | 000 |
| H6792424770 | K012114 | 000 |
| H6792128300 | K012114 | 000 |
| H6792128280 | K012114 | 000 |
| H6792128260 | K012114 | 000 |
| H6792424930 | K012114 | 000 |
| H6792424940 | K012114 | 000 |
| H6792425000 | K012114 | 000 |
| H6794128200 | K012114 | 000 |
| H6792425120 | K012114 | 000 |
| H6792425110 | K012114 | 000 |
| H6792425090 | K012114 | 000 |
| H6792425080 | K012114 | 000 |
| H6792425070 | K012114 | 000 |
| H6792425060 | K012114 | 000 |
| H6792425040 | K012114 | 000 |
| H6792425020 | K012114 | 000 |
| H6792128240 | K012114 | 000 |
| H6792128180 | K012114 | 000 |
| H6792001930 | K012114 | 000 |
| H6792001920 | K012114 | 000 |
| H6792001910 | K012114 | 000 |
| H6792001900 | K012114 | 000 |
| 10886982261632 | K012114 | 000 |
| 10886982261625 | K012114 | 000 |
| 10886982261618 | K012114 | 000 |
| 10886982261601 | K012114 | 000 |
| 10886982261595 | K012114 | 000 |
| H6792001940 | K012114 | 000 |
| H6792001950 | K012114 | 000 |
| H6792001960 | K012114 | 000 |
| H6792128160 | K012114 | 000 |
| H6792128140 | K012114 | 000 |
| H6792128120 | K012114 | 000 |
| H6792128100 | K012114 | 000 |
| H6792128080 | K012114 | 000 |
| H6792128060 | K012114 | 000 |
| H6792001990 | K012114 | 000 |
| H6792001980 | K012114 | 000 |
| H6792001970 | K012114 | 000 |
| 10886982261588 | K012114 | 000 |