The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Titanium Lcp Proximal Tibia Plates.
| Device ID | K030597 |
| 510k Number | K030597 |
| Device Name: | SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES |
| 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 | 2003-02-25 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794399340 | K030597 | 000 |
| H679439941S0 | K030597 | 000 |
| H6794399420 | K030597 | 000 |
| H679439942S0 | K030597 | 000 |
| H6794399430 | K030597 | 000 |
| H679439943S0 | K030597 | 000 |
| H6794399440 | K030597 | 000 |
| H679439944S0 | K030597 | 000 |
| H6794399450 | K030597 | 000 |
| H679439945S0 | K030597 | 000 |
| H6794399460 | K030597 | 000 |
| H679439946S0 | K030597 | 000 |
| H6794399470 | K030597 | 000 |
| H6794399410 | K030597 | 000 |
| H679439940S0 | K030597 | 000 |
| H679439934S0 | K030597 | 000 |
| H6794399350 | K030597 | 000 |
| H679439935S0 | K030597 | 000 |
| H6794399360 | K030597 | 000 |
| H679439936S0 | K030597 | 000 |
| H6794399370 | K030597 | 000 |
| H679439937S0 | K030597 | 000 |
| H6794399380 | K030597 | 000 |
| H679439938S0 | K030597 | 000 |
| H6794399390 | K030597 | 000 |
| H679439939S0 | K030597 | 000 |
| H6794399400 | K030597 | 000 |
| H679439947S0 | K030597 | 000 |
| H679041242000 | K030597 | 000 |
| H67904124213S0 | K030597 | 000 |
| H679041242160 | K030597 | 000 |
| H67904124216S0 | K030597 | 000 |
| H679041242170 | K030597 | 000 |
| H67904124217S0 | K030597 | 000 |
| H679041242200 | K030597 | 000 |
| H67904124220S0 | K030597 | 000 |
| H679041242210 | K030597 | 000 |
| H67904124221S0 | K030597 | 000 |
| H679041242240 | K030597 | 000 |
| H67904124224S0 | K030597 | 000 |
| H679041242250 | K030597 | 000 |
| H679041242130 | K030597 | 000 |
| H67904124212S0 | K030597 | 000 |
| H67904124200S0 | K030597 | 000 |
| H679041242010 | K030597 | 000 |
| H67904124201S0 | K030597 | 000 |
| H679041242040 | K030597 | 000 |
| H67904124204S0 | K030597 | 000 |
| H679041242050 | K030597 | 000 |
| H67904124205S0 | K030597 | 000 |
| H679041242080 | K030597 | 000 |
| H67904124208S0 | K030597 | 000 |
| H679041242090 | K030597 | 000 |
| H67904124209S0 | K030597 | 000 |
| H679041242120 | K030597 | 000 |
| H67904124225S0 | K030597 | 000 |