The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Proximal Femur Plate And Screws.
| Device ID | K030858 |
| 510k Number | K030858 |
| Device Name: | SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle 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 | 2003-03-18 |
| Decision Date | 2003-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679242816S0 | K030858 | 000 |
| H6792421160 | K030858 | 000 |
| H679242114S0 | K030858 | 000 |
| H6792421140 | K030858 | 000 |
| H679242112S0 | K030858 | 000 |
| H6792421120 | K030858 | 000 |
| H679242110S0 | K030858 | 000 |
| H6792421100 | K030858 | 000 |
| H679242108S0 | K030858 | 000 |
| H6792421080 | K030858 | 000 |
| H679242106S0 | K030858 | 000 |
| H6792421060 | K030858 | 000 |
| H679242104S0 | K030858 | 000 |
| H6792421040 | K030858 | 000 |
| H679242102S0 | K030858 | 000 |
| H679242116S0 | K030858 | 000 |
| H6792428020 | K030858 | 000 |
| H6792428160 | K030858 | 000 |
| H679242814S0 | K030858 | 000 |
| H6792428140 | K030858 | 000 |
| H679242812S0 | K030858 | 000 |
| H6792428120 | K030858 | 000 |
| H679242810S0 | K030858 | 000 |
| H6792428100 | K030858 | 000 |
| H679242808S0 | K030858 | 000 |
| H6792428080 | K030858 | 000 |
| H679242806S0 | K030858 | 000 |
| H6792428060 | K030858 | 000 |
| H679242804S0 | K030858 | 000 |
| H6792428040 | K030858 | 000 |
| H679242802S0 | K030858 | 000 |
| H6792421020 | K030858 | 000 |