The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Proximal Tibia Plates Line Extension.
| Device ID | K052390 |
| 510k Number | K052390 |
| Device Name: | SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2005-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794222200 | K052390 | 000 |
| H679422226S0 | K052390 | 000 |
| H6794222270 | K052390 | 000 |
| H679422227S0 | K052390 | 000 |
| H6794222280 | K052390 | 000 |
| H679422228S0 | K052390 | 000 |
| H6794222290 | K052390 | 000 |
| H679422229S0 | K052390 | 000 |
| H6792222200 | K052390 | 000 |
| H679222220S0 | K052390 | 000 |
| H6794222260 | K052390 | 000 |
| H679422225S0 | K052390 | 000 |
| H6794222250 | K052390 | 000 |
| H679422220S0 | K052390 | 000 |
| H6794222210 | K052390 | 000 |
| H679422221S0 | K052390 | 000 |
| H6794222220 | K052390 | 000 |
| H679422222S0 | K052390 | 000 |
| H6794222230 | K052390 | 000 |
| H679422223S0 | K052390 | 000 |
| H6794222240 | K052390 | 000 |
| H679422224S0 | K052390 | 000 |
| H6792222210 | K052390 | 000 |
| H679222221S0 | K052390 | 000 |
| H6792222280 | K052390 | 000 |
| H679222228S0 | K052390 | 000 |
| H6792222290 | K052390 | 000 |
| H679222229S0 | K052390 | 000 |
| H679240048S0 | K052390 | 000 |
| H679240049S0 | K052390 | 000 |
| H679240052S0 | K052390 | 000 |
| H679240053S0 | K052390 | 000 |
| H679240054S0 | K052390 | 000 |
| H679222227S0 | K052390 | 000 |
| H6792222270 | K052390 | 000 |
| H679222226S0 | K052390 | 000 |
| H6792222220 | K052390 | 000 |
| H679222222S0 | K052390 | 000 |
| H6792222230 | K052390 | 000 |
| H679222223S0 | K052390 | 000 |
| H6792222240 | K052390 | 000 |
| H679222224S0 | K052390 | 000 |
| H6792222250 | K052390 | 000 |
| H679222225S0 | K052390 | 000 |
| H6792222260 | K052390 | 000 |
| H679240055S0 | K052390 | 000 |