The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Medial Distal Tibia Plates.
| Device ID | K001945 |
| 510k Number | K001945 |
| Device Name: | SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES |
| Classification | Plate, Fixation, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794064140 | K001945 | 000 |
| H6794064850 | K001945 | 000 |
| H6794064800 | K001945 | 000 |
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| H6792245060 | K001945 | 000 |
| H6792235190 | K001945 | 000 |
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| H6792235170 | K001945 | 000 |
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| H6792245070 | K001945 | 000 |
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| H6792245140 | K001945 | 000 |
| H6792245130 | K001945 | 000 |
| H6792245120 | K001945 | 000 |
| H6792245110 | K001945 | 000 |
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| H6792245090 | K001945 | 000 |
| H6792235120 | K001945 | 000 |
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| H6794245100 | K001945 | 000 |
| H6794245090 | K001945 | 000 |
| H6794245080 | K001945 | 000 |
| H6794245070 | K001945 | 000 |
| H6794245060 | K001945 | 000 |
| H6794235170 | K001945 | 000 |
| H6794235160 | K001945 | 000 |
| H6794235150 | K001945 | 000 |
| H6794245110 | K001945 | 000 |
| H6794245120 | K001945 | 000 |
| H6792235100 | K001945 | 000 |
| H6792235090 | K001945 | 000 |
| H6792235080 | K001945 | 000 |
| H6792235070 | K001945 | 000 |
| H6792235060 | K001945 | 000 |
| H6794245150 | K001945 | 000 |
| H6794245140 | K001945 | 000 |
| H6794245130 | K001945 | 000 |
| H6794235190 | K001945 | 000 |