The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5 Mm Broad Lc-dcp Plates.
| Device ID | K020872 |
| 510k Number | K020872 |
| Device Name: | SYNTHES 3.5 MM BROAD LC-DCP PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. 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 | 2002-03-18 |
| Decision Date | 2002-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792250120 | K020872 | 000 |
| H6792250080 | K020872 | 000 |
| H6792250090 | K020872 | 000 |
| H6792250100 | K020872 | 000 |
| H6792250110 | K020872 | 000 |
| H6792250130 | K020872 | 000 |
| H6792250140 | K020872 | 000 |
| H6792250150 | K020872 | 000 |
| H6792250160 | K020872 | 000 |
| H6792250170 | K020872 | 000 |
| H6792250180 | K020872 | 000 |
| H6792250200 | K020872 | 000 |
| H6792250220 | K020872 | 000 |
| H6792250070 | K020872 | 000 |