The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Distal Femur Plates.
| Device ID | K062564 |
| 510k Number | K062564 |
| Device Name: | SYNTHES LCP DISTAL FEMUR PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-31 |
| Decision Date | 2006-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794222500 | K062564 | 000 |
| H6794222570 | K062564 | 000 |
| H679422257S0 | K062564 | 000 |
| H6794222580 | K062564 | 000 |
| H679422258S0 | K062564 | 000 |
| H6794222590 | K062564 | 000 |
| H679422259S0 | K062564 | 000 |
| H67904124030S0 | K062564 | 000 |
| H67904124031S0 | K062564 | 000 |
| H67904124034S0 | K062564 | 000 |
| H67904124035S0 | K062564 | 000 |
| H67904124038S0 | K062564 | 000 |
| H679422256S0 | K062564 | 000 |
| H6794222560 | K062564 | 000 |
| H679422250S0 | K062564 | 000 |
| H6794222510 | K062564 | 000 |
| H679422251S0 | K062564 | 000 |
| H6794222520 | K062564 | 000 |
| H679422252S0 | K062564 | 000 |
| H6794222530 | K062564 | 000 |
| H679422253S0 | K062564 | 000 |
| H6794222540 | K062564 | 000 |
| H679422254S0 | K062564 | 000 |
| H6794222550 | K062564 | 000 |
| H679422255S0 | K062564 | 000 |
| H67904124039S0 | K062564 | 000 |
| H6792222500 | K062564 | 000 |
| H6792222570 | K062564 | 000 |
| H679222257S0 | K062564 | 000 |
| H6792222580 | K062564 | 000 |
| H679222258S0 | K062564 | 000 |
| H6792222590 | K062564 | 000 |
| H679222259S0 | K062564 | 000 |
| H67902124030S0 | K062564 | 000 |
| H67902124031S0 | K062564 | 000 |
| H67902124034S0 | K062564 | 000 |
| H67902124035S0 | K062564 | 000 |
| H67902124038S0 | K062564 | 000 |
| H679222256S0 | K062564 | 000 |
| H6792222560 | K062564 | 000 |
| H679222250S0 | K062564 | 000 |
| H6792222510 | K062564 | 000 |
| H679222251S0 | K062564 | 000 |
| H6792222520 | K062564 | 000 |
| H679222252S0 | K062564 | 000 |
| H6792222530 | K062564 | 000 |
| H679222253S0 | K062564 | 000 |
| H6792222540 | K062564 | 000 |
| H679222254S0 | K062564 | 000 |
| H6792222550 | K062564 | 000 |
| H679222255S0 | K062564 | 000 |
| H67902124039S0 | K062564 | 000 |