The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 3.5 Mm Lcp Distal Humerus System.
| Device ID | K033995 |
| 510k Number | K033995 |
| Device Name: | 3.5 MM LCP DISTAL HUMERUS SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
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|---|---|---|
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