The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Proximal Tibia Plate.
| Device ID | K011978 |
| 510k Number | K011978 |
| Device Name: | SYNTHES LCP PROXIMAL TIBIA PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-25 |
| Decision Date | 2001-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792399340 | K011978 | 000 |
| H6792400360 | K011978 | 000 |
| H679239947S0 | K011978 | 000 |
| H6792399470 | K011978 | 000 |
| H679239946S0 | K011978 | 000 |
| H6792399460 | K011978 | 000 |
| H679239945S0 | K011978 | 000 |
| H6792399450 | K011978 | 000 |
| H679239944S0 | K011978 | 000 |
| H679240036S0 | K011978 | 000 |
| H6792400370 | K011978 | 000 |
| H6792400410 | K011978 | 000 |
| H679240040S0 | K011978 | 000 |
| H6792400400 | K011978 | 000 |
| H679240039S0 | K011978 | 000 |
| H6792400390 | K011978 | 000 |
| H679240038S0 | K011978 | 000 |
| H6792400380 | K011978 | 000 |
| H679240037S0 | K011978 | 000 |
| H6792399440 | K011978 | 000 |
| H679239943S0 | K011978 | 000 |
| H6792399380 | K011978 | 000 |
| H679239937S0 | K011978 | 000 |
| H6792399370 | K011978 | 000 |
| H679239936S0 | K011978 | 000 |
| H6792399360 | K011978 | 000 |
| H679239935S0 | K011978 | 000 |
| H6792399350 | K011978 | 000 |
| H679239934S0 | K011978 | 000 |
| H679239938S0 | K011978 | 000 |
| H6792399390 | K011978 | 000 |
| H6792399430 | K011978 | 000 |
| H679239942S0 | K011978 | 000 |
| H6792399420 | K011978 | 000 |
| H679239941S0 | K011978 | 000 |
| H6792399410 | K011978 | 000 |
| H679239940S0 | K011978 | 000 |
| H6792399400 | K011978 | 000 |
| H679239939S0 | K011978 | 000 |
| H679240041S0 | K011978 | 000 |
| H6792400420 | K011978 | 000 |
| H679021242160 | K011978 | 000 |
| H67902124213S0 | K011978 | 000 |
| H679021242130 | K011978 | 000 |
| H67902124212S0 | K011978 | 000 |
| H679021242120 | K011978 | 000 |
| H67902124209S0 | K011978 | 000 |
| H679021242090 | K011978 | 000 |
| H67902124208S0 | K011978 | 000 |
| H67902124216S0 | K011978 | 000 |
| H679021242170 | K011978 | 000 |
| H679021242250 | K011978 | 000 |
| H67902124224S0 | K011978 | 000 |
| H679021242240 | K011978 | 000 |
| H67902124221S0 | K011978 | 000 |
| H679021242210 | K011978 | 000 |
| H67902124220S0 | K011978 | 000 |
| H679021242200 | K011978 | 000 |
| H67902124217S0 | K011978 | 000 |
| H679021242080 | K011978 | 000 |
| H67902124205S0 | K011978 | 000 |
| H6792400460 | K011978 | 000 |
| H679240045S0 | K011978 | 000 |
| H6792400450 | K011978 | 000 |
| H679240044S0 | K011978 | 000 |
| H6792400440 | K011978 | 000 |
| H679240043S0 | K011978 | 000 |
| H6792400430 | K011978 | 000 |
| H679240042S0 | K011978 | 000 |
| H679240046S0 | K011978 | 000 |
| H6792400470 | K011978 | 000 |
| H679021242050 | K011978 | 000 |
| H67902124204S0 | K011978 | 000 |
| H679021242040 | K011978 | 000 |
| H67902124201S0 | K011978 | 000 |
| H679021242010 | K011978 | 000 |
| H67902124200S0 | K011978 | 000 |
| H679021242000 | K011978 | 000 |
| H679240047S0 | K011978 | 000 |
| H67902124225S0 | K011978 | 000 |