The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Distal Tibia Plates.
| Device ID | K013248 |
| 510k Number | K013248 |
| Device Name: | SYNTHES LCP DISTAL TIBIA PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull 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 | 2001-09-28 |
| Decision Date | 2001-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902112523S0 | K013248 | 000 |
| H67902112511S0 | K013248 | 000 |
| H679021125110 | K013248 | 000 |
| H67902112510S0 | K013248 | 000 |
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