The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Vectra-t System.
| Device ID | K051665 |
| 510k Number | K051665 |
| Device Name: | SYNTHES VECTRA-T SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES SPINE 1380 ENTERPRISE DR. West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-22 |
| Decision Date | 2005-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9814505910 | K051665 | 000 |
| H981450570 | K051665 | 000 |
| H9814505690 | K051665 | 000 |
| H9814505680 | K051665 | 000 |
| H9814505670 | K051665 | 000 |
| H9814505660 | K051665 | 000 |
| H9814505650 | K051665 | 000 |
| H9814505640 | K051665 | 000 |
| H9814505630 | K051665 | 000 |
| H9814505620 | K051665 | 000 |
| H9814505610 | K051665 | 000 |
| H9814505570 | K051665 | 000 |
| H9814505560 | K051665 | 000 |
| H9814505550 | K051665 | 000 |
| H9814505540 | K051665 | 000 |
| H9814505530 | K051665 | 000 |
| H9814505520 | K051665 | 000 |
| H9814505710 | K051665 | 000 |
| H9814505720 | K051665 | 000 |
| H9814505730 | K051665 | 000 |
| H9814505900 | K051665 | 000 |
| H9814505890 | K051665 | 000 |
| H9814505880 | K051665 | 000 |
| H9814505870 | K051665 | 000 |
| H9814505860 | K051665 | 000 |
| H9814505850 | K051665 | 000 |
| H9814505840 | K051665 | 000 |
| H9814505830 | K051665 | 000 |
| H9814505820 | K051665 | 000 |
| H9814505810 | K051665 | 000 |
| H9814505790 | K051665 | 000 |
| H9814505780 | K051665 | 000 |
| H9814505770 | K051665 | 000 |
| H9814505760 | K051665 | 000 |
| H9814505750 | K051665 | 000 |
| H9814505740 | K051665 | 000 |
| H9814505510 | K051665 | 000 |