The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Lcp Radial Head Plating System.
| Device ID | K040777 |
| 510k Number | K040777 |
| Device Name: | LCP RADIAL HEAD PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle 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 | 2004-03-26 |
| Decision Date | 2004-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794416830 | K040777 | 000 |
| H6794416840 | K040777 | 000 |
| H6794416850 | K040777 | 000 |
| H6794416900 | K040777 | 000 |
| H6794416910 | K040777 | 000 |
| H6794416920 | K040777 | 000 |
| H6792416800 | K040777 | 000 |
| H6792416810 | K040777 | 000 |
| H6792416820 | K040777 | 000 |
| H6792416830 | K040777 | 000 |
| H6792416840 | K040777 | 000 |
| H6792416850 | K040777 | 000 |
| H6792416900 | K040777 | 000 |
| H6792416910 | K040777 | 000 |
| H6792416920 | K040777 | 000 |
| H6794416810 | K040777 | 000 |
| H6794416820 | K040777 | 000 |
| H6794416800 | K040777 | 000 |