The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Vectra System.
| Device ID | K050451 |
| 510k Number | K050451 |
| Device Name: | SYNTHES VECTRA SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H981046131340 | K050451 | 000 |
| H981046131300 | K050451 | 000 |
| H981046131320 | K050451 | 000 |
| H981046131360 | K050451 | 000 |
| H981046131380 | K050451 | 000 |
| H981046131400 | K050451 | 000 |
| H981046131420 | K050451 | 000 |
| H981046131440 | K050451 | 000 |
| H981046131460 | K050451 | 000 |
| H981046131280 | K050451 | 000 |
| H981046131260 | K050451 | 000 |
| H981046130120 | K050451 | 000 |
| H981046130140 | K050451 | 000 |
| H981046130160 | K050451 | 000 |
| H981046130180 | K050451 | 000 |
| H981046130200 | K050451 | 000 |
| H981046130220 | K050451 | 000 |
| H981046130240 | K050451 | 000 |
| H981046130260 | K050451 | 000 |
| H981046132390 | K050451 | 000 |
| H981046132420 | K050451 | 000 |
| H981046132450 | K050451 | 000 |
| H981046133680 | K050451 | 000 |
| H981046133720 | K050451 | 000 |
| H981046133760 | K050451 | 000 |
| H981046133800 | K050451 | 000 |
| H981046133840 | K050451 | 000 |
| H981046133880 | K050451 | 000 |
| H981046133920 | K050451 | 000 |
| H981046133960 | K050451 | 000 |
| H981046133640 | K050451 | 000 |
| H981046133600 | K050451 | 000 |
| H981046132480 | K050451 | 000 |
| H981046132510 | K050451 | 000 |
| H981046132540 | K050451 | 000 |
| H981046132570 | K050451 | 000 |
| H981046132600 | K050451 | 000 |
| H981046132630 | K050451 | 000 |
| H981046132660 | K050451 | 000 |
| H981046132690 | K050451 | 000 |
| H981046134000 | K050451 | 000 |