The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Dorsal Distal Radius Plate (ddrp) System.
Device ID | K962616 |
510k Number | K962616 |
Device Name: | SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Angela J Silvestri |
Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-03 |
Decision Date | 1996-09-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679401968960 | K962616 | 000 |