The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Locking Proximal Plating (l-ptp) System.
Device ID | K002361 |
510k Number | K002361 |
Device Name: | SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Bonnie J Smith |
Correspondent | Bonnie J Smith 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 | 2000-08-03 |
Decision Date | 2000-10-31 |