VERTEX® Reconstruction System
GUDID 00613994354525
SCREW 6958922 4.5 X 22MM MAS
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994354525 |
| NIH Device Record Key | 0eaa2ea7-c316-4724-a71e-197ef69fa1f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERTEX® Reconstruction System |
| Version Model Number | 6958922 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994354525 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042789
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
[00613994354525]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-07-27 |
On-Brand Devices [VERTEX® Reconstruction System]
| 00613994932433 | Connector 7753619 Open Lateral 19mm |
| 00613994901187 | X LINK X0710382 VER SEL MAS XS 26/30MM |
| 00613994763716 | PLATE X0310008 VER OC ADJUSTABLE SM |
| 00613994738127 | SCR X0909575 VER TI CORT BLNTTIP 4.0X6 |
| 00613994738110 | SCR X0909576 VER TI CORT BLNTTIP 4.0X8 |
| 00613994738103 | SCR X0909577 VER TI CORT BLNTTIP 4.0X10 |
| 00613994738097 | SCR X0909578 VER TI CORT BLNTTIP 4.0X12 |
| 00613994738080 | SCR X0909579 VER TI CORT BLNTTIP 4.0X14 |
| 00613994738073 | SCR X0909580 VER TI CORT BLNTTIP 4.0X16 |
| 00613994738066 | SCR X0909581 VER TI CORT BLNTTIP 4.0X18 |
| 00613994738059 | SCR X0909582 VER TI CORT BLNTTIP 4.5X6 |
| 00613994738042 | SCR X0909583 VER TI CORT BLNTTIP 4.5X8 |
| 00613994738035 | SCR X0909584 VER TI CORT BLNTTIP 4.5X10 |
| 00613994738028 | SCR X0909585 VER TI CORT BLNTTIP 4.5X12 |
| 00613994738011 | SCR X0909586 VER TI CORT BLNTTIP 4.5X14 |
| 00613994738004 | SCR X0909587 VER TI CORT BLNTTIP 4.5X16 |
| 00613994737991 | SCR X0909588 VER TI CORT BLNTTIP 4.5X18 |
| 00613994737984 | SCR X0909589 VER TI CORT BLNTTIP 5.0X6 |
| 00613994737977 | SCR X0909590 VER TI CORT BLNTTIP 5.0X8 |
| 00613994737960 | SCR X0909591 VER TI CORT BLNTTIP 5.0X10 |
| 00613994737953 | SCR X0909592 VER TI CORT BLNTTIP 5.0X12 |
| 00613994737946 | SCR X0909593 VER TI CORT BLNTTIP 5.0X14 |
| 00613994737939 | SCR X0909594 VER TI CORT BLNTTIP 5.0X16 |
| 00613994737922 | SCR X0909595 VER TI CORT BLNTTIP 5.0X18 |
| 00613994718266 | TRAY 7757258 INSTRUMENT 2 OF 4 |
| 00613994667373 | SCREW G7750518 OC SCREW 4.5 X 18MM |
| 00613994667335 | SCREW G7750606 OC SCREW 5.0 X 6MM |
| 00613994667328 | SCREW G7750608 OC SCREW 5.0 X 8MM |
| 00613994667311 | SCREW G7750610 OC SCREW 5.0 X 10MM |
| 00613994667304 | SCREW G7750612 OC SCREW 5.0 X 12MM |
| 00613994667298 | SCREW G7750614 OC SCREW 5.0 X 14MM |
| 00613994667281 | SCREW G7750616 OC SCREW 5.0 X 16MM |
| 00613994667274 | SCREW G7750618 OC SCREW 5.0 X 18MM |
| 00613994667199 | ROD G7755124 ADJ ROD 3.5MM X 220MM |
| 00613994667052 | SCREW G7750506 OC SCREW 4.5 X 6MM |
| 00613994667045 | SCREW G7750508 OC SCREW 4.5 X 8MM |
| 00613994667038 | SCREW G7750510 OC SCREW 4.5 X 10MM |
| 00613994667021 | SCREW G7750512 OC SCREW 4.5 X 12MM |
| 00613994667014 | SCREW G7750514 OC SCREW 4.5 X 14MM |
| 00613994667007 | SCREW G7750516 OC SCREW 4.5 X 16MM |
| 00613994666949 | PLATE G7755278 OC MIDLINE TRANSLATIONAL |
| 00613994666918 | CONNECTOR G7755325 LP OC SCREW CONNECTOR |
| 00613994666901 | CONNECTOR G7755327 OFFSET LP OC SCREW CO |
| 00613994666833 | PLATE G7759970 LP OC MIDLINE M-SHAPED S |
| 00613994666826 | PLATE G7759971 LP OC MIDLINE M-SHAPED M |
| 00613994666819 | PLATE G7759972 LP OC MIDLINE M-SHAPED L |
| 00613994666635 | ROD G7755271 PRE-BENT 3.5 X 200MM |
| 00613994641915 | ROD G7750088 COBALT CHROME 3.5 X 300MM |
| 00613994597601 | CONNECTOR X1108073 LAT TI 45DEG 13MM 3.5 |
| 00613994578143 | ROD X0209552 TI 3.2 X 20MM |
Trademark Results [VERTEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTEX 98887762 not registered Live/Pending |
Vertex Energy Operating, LLC 2024-12-05 |
 VERTEX 98620698 not registered Live/Pending |
Amer Sports Canada Inc. 2024-06-26 |
 VERTEX 98418366 not registered Live/Pending |
Albaugh, LLC 2024-02-23 |
 VERTEX 98418165 not registered Live/Pending |
Eos Positioning Systems Inc. 2024-02-23 |
 VERTEX 98283922 not registered Live/Pending |
SMB DOLLAR INC. 2023-11-24 |
 VERTEX 98003838 not registered Live/Pending |
Guangdong Xupai New Energy Co., LTD 2023-05-18 |
 VERTEX 97926020 not registered Live/Pending |
BOSU Fitness, LLC 2023-05-08 |
 VERTEX 97842957 not registered Live/Pending |
Tony Wang 2023-03-16 |
 VERTEX 97810328 not registered Live/Pending |
Neptune Medical Inc. 2023-02-24 |
 VERTEX 97717621 not registered Live/Pending |
Alliance Sports Group, L.P. 2022-12-14 |
 VERTEX 97649858 not registered Live/Pending |
Alliance Sports Group, L.P. 2022-10-26 |
 VERTEX 97641291 not registered Live/Pending |
SeeScan, Inc. 2022-10-20 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.