The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.5 Mm Lcp Straight Reconstruction Plates.
| Device ID | K051986 |
| 510k Number | K051986 |
| Device Name: | SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung 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 | 2005-07-22 |
| Decision Date | 2005-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792294610 | K051986 | 000 |
| H6794294510 | K051986 | 000 |
| H6794294410 | K051986 | 000 |
| H6794294310 | K051986 | 000 |
| H6794294210 | K051986 | 000 |
| H6794294110 | K051986 | 000 |
| H6794294010 | K051986 | 000 |
| H6794293910 | K051986 | 000 |
| H6794293810 | K051986 | 000 |
| H6794293710 | K051986 | 000 |
| H6794293610 | K051986 | 000 |
| H6794293510 | K051986 | 000 |
| H6794293410 | K051986 | 000 |
| H6794294610 | K051986 | 000 |
| H6792293310 | K051986 | 000 |
| H6792294510 | K051986 | 000 |
| H6792294410 | K051986 | 000 |
| H6792294310 | K051986 | 000 |
| H6792294210 | K051986 | 000 |
| H6792294110 | K051986 | 000 |
| H6792294010 | K051986 | 000 |
| H6792293910 | K051986 | 000 |
| H6792293810 | K051986 | 000 |
| H6792293710 | K051986 | 000 |
| H6792293610 | K051986 | 000 |
| H6792293510 | K051986 | 000 |
| H6792293410 | K051986 | 000 |
| H6794293310 | K051986 | 000 |