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 |