The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Calvicle Hook Plate.
| Device ID | K031677 |
| 510k Number | K031677 |
| Device Name: | SYNTHES (USA) CALVICLE HOOK PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith 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 | 2003-05-30 |
| Decision Date | 2003-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794410690 | K031677 | 000 |
| H6792410630 | K031677 | 000 |
| H6792410640 | K031677 | 000 |
| H6792410650 | K031677 | 000 |
| H6792410660 | K031677 | 000 |
| H6792410670 | K031677 | 000 |
| H6792410680 | K031677 | 000 |
| H6792410690 | K031677 | 000 |
| H6794410620 | K031677 | 000 |
| H6794410630 | K031677 | 000 |
| H6794410640 | K031677 | 000 |
| H6794410650 | K031677 | 000 |
| H6794410660 | K031677 | 000 |
| H6794410670 | K031677 | 000 |
| H6794410680 | K031677 | 000 |
| H6792410620 | K031677 | 000 |