The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.0 Mm Locking Plate System (2.0 Lps).
| Device ID | K974555 |
| 510k Number | K974555 |
| Device Name: | SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-04 |
| Decision Date | 1998-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980SD4470530 | K974555 | 000 |
| H9804470550 | K974555 | 000 |
| H9804470570 | K974555 | 000 |
| H9804471010 | K974555 | 000 |
| H9804471020 | K974555 | 000 |
| H9804471030 | K974555 | 000 |
| H9804471040 | K974555 | 000 |
| H9804471050 | K974555 | 000 |
| H9804471060 | K974555 | 000 |
| H9804471080 | K974555 | 000 |
| H9804471090 | K974555 | 000 |
| H9804471170 | K974555 | 000 |
| H9804471180 | K974555 | 000 |
| H9804471190 | K974555 | 000 |
| H9804472040 | K974555 | 000 |
| H9804472050 | K974555 | 000 |
| H9804472060 | K974555 | 000 |
| H9804470530 | K974555 | 000 |
| H9804470510 | K974555 | 000 |
| H9804470500 | K974555 | 000 |
| H980SD4470550 | K974555 | 000 |
| H980401291E0 | K974555 | 000 |
| H980401292E0 | K974555 | 000 |
| H980401294E0 | K974555 | 000 |
| H980401295E0 | K974555 | 000 |
| H980401296E0 | K974555 | 000 |
| H980401297E0 | K974555 | 000 |
| H980401298E0 | K974555 | 000 |
| H980401299E0 | K974555 | 000 |
| H980401955E0 | K974555 | 000 |
| H980401956E0 | K974555 | 000 |
| H980401957E0 | K974555 | 000 |
| H9804470460 | K974555 | 000 |
| H9804470470 | K974555 | 000 |
| H9804470480 | K974555 | 000 |
| H9804470490 | K974555 | 000 |
| H9804472080 | K974555 | 000 |
| H9804472100 | K974555 | 000 |
| H9804474230 | K974555 | 000 |
| H9804474240 | K974555 | 000 |
| H9804474250 | K974555 | 000 |
| H9804474260 | K974555 | 000 |
| H9804490170 | K974555 | 000 |
| H9804492500 | K974555 | 000 |
| H9804012910 | K974555 | 000 |
| H9804012920 | K974555 | 000 |
| H9804012940 | K974555 | 000 |
| H9804012950 | K974555 | 000 |
| H9804012960 | K974555 | 000 |
| H9804012970 | K974555 | 000 |
| H9804012980 | K974555 | 000 |
| H9804012990 | K974555 | 000 |
| H9804019550 | K974555 | 000 |
| H9804019560 | K974555 | 000 |
| H9804474220 | K974555 | 000 |
| H9804474200 | K974555 | 000 |
| H9804474120 | K974555 | 000 |
| H9804472120 | K974555 | 000 |
| H9804472150 | K974555 | 000 |
| H9804472170 | K974555 | 000 |
| H9804473040 | K974555 | 000 |
| H9804473050 | K974555 | 000 |
| H9804473080 | K974555 | 000 |
| H9804473090 | K974555 | 000 |
| H9804473100 | K974555 | 000 |
| H9804473120 | K974555 | 000 |
| H9804473150 | K974555 | 000 |
| H9804473170 | K974555 | 000 |
| H9804473180 | K974555 | 000 |
| H9804473190 | K974555 | 000 |
| H9804474040 | K974555 | 000 |
| H9804474050 | K974555 | 000 |
| H9804474060 | K974555 | 000 |
| H9804019570 | K974555 | 000 |