The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5/4.5mm Lcp Medial Proximal Tibia Plates.
| Device ID | K032269 |
| 510k Number | K032269 |
| Device Name: | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 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 | 2003-07-23 |
| Decision Date | 2003-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792399580 | K032269 | 000 |
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