The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Distal Femur Plate (dfp) System.
Device ID | K982222 |
510k Number | K982222 |
Device Name: | SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
Product Code | HWC |
Subsequent Product Code | HRS |
Subsequent Product Code | HTY |
Subsequent Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-24 |
Decision Date | 1998-07-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679SD2926800 | K982222 | 000 |
H6799007260 | K982222 | 000 |
H6799007230 | K982222 | 000 |