VersaLink™ Fixation System
GUDID 07290014064133
VersaLink Rod No Offset, 0°, 90 mm The VersaLink Fixation System is a titanium fusion construct that is designed to connect proximally or distally to a fusion crossbar. The VersaLink Fixation System uses Polyaxial Head Pedicle Screws for fixation to the vertebrae.
PREMIA SPINE LTD
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 07290014064133 |
| NIH Device Record Key | a491beab-53ba-4c95-8157-2f7fbe2dc6e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VersaLink™ Fixation System |
| Version Model Number | 82565 |
| Company DUNS | 649220779 |
| Company Name | PREMIA SPINE LTD |
| 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 | true |
| 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 |
Device Dimensions
| Length | 90 Millimeter |
| Angle | 0 degree |
| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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| Length | 90 Millimeter |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290014064133 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182598
FDA Product Code
| NKB | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
[07290014064133]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-22 |
| Device Publish Date | 2024-02-14 |
On-Brand Devices [VersaLink™ Fixation System]
| 07290115931440 | VersaLink Rod Posterior Offset, 0°, 45 mm The VersaLinkTM Fixation System is a titanium fusion |
| 07290115931655 | VersaLink™ Rod Anterior Offset 0°, 120 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931631 | VersaLink™ Rod Anterior Offset 0°, 85 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931310 | VersaLink™ Rod Anterior Offset 15°, 90 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931303 | VersaLink™ Rod Anterior Offset 15°, 85 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931297 | VersaLink™ Rod Anterior Offset 15°, 80 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931280 | VersaLink™ Rod Anterior Offset 15°, 75 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931273 | VersaLink™ Rod Anterior Offset 15°, 70 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931266 | VersaLink™ Rod Anterior Offset 15°, 65 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931259 | VersaLink™ Rod Anterior Offset 15°, 60 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931242 | VersaLink™ Rod Anterior Offset 15°, 55 mm The VersaLink Fixation System is a titanium fusion |
| 07290115931228 | VersaLink™ Rod Anterior Offset 15°, 45 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930986 | VersaLink™ Rod Anterior Offset 30°, 90 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930979 | VersaLink™ Rod Anterior Offset 30°, 85 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930962 | VersaLink™ Rod Anterior Offset 30°, 80 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930955 | VersaLink™ Rod Anterior Offset 30°, 75 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930948 | VersaLink™ Rod Anterior Offset 30°, 70 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930931 | VersaLink™ Rod Anterior Offset 30°, 65 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930924 | VersaLink™ Rod Anterior Offset 30°, 60 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930917 | VersaLink™ Rod Anterior Offset 30°, 55 mm The VersaLink Fixation System is a titanium fusion |
| 07290115930894 | VersaLink™ Rod Anterior Offset 30°, 45 mm The VersaLink Fixation System is a titanium fusion |
| 07290014064492 | VersaLink™ Rod Anterior Offset 30°, 50 mm The VersaLink Fixation System is a titanium fusion |
| 07290014064485 | VersaLink™ Rod Anterior Offset 30°, 40 mm The VersaLink Fixation System is a titanium fusion |
| 07290014064430 | VersaLink™ Rod Anterior Offset 15°, 50 mm The VersaLink Fixation System is a titanium fusion |
| 07290014064423 | VersaLink™ Rod Anterior Offset 15°, 40 mm The VersaLink Fixation System is a titanium fusion |
| 07290014064416 | VersaLink™ Rod Anterior Offset 0°, 90 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931679 | VersaLink Rod No Offset, 0°, 120 mm The VersaLink Fixation System is a titanium fusion construc |
| 07290115931662 | VersaLink Rod Posterior Offset, 0°, 120 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931624 | VersaLink™ Rod Anterior Offset 0°, 80 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931617 | VersaLink™ Rod Anterior Offset 0°, 75 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931600 | VersaLink™ Rod Anterior Offset 0°, 70 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931594 | VersaLink™ Rod Anterior Offset 0°, 65 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931587 | VersaLink™ Rod Anterior Offset 0°, 60 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931570 | VersaLink™ Rod Anterior Offset 0°, 55 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931556 | VersaLink™ Rod Anterior Offset 0°, 45 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931525 | VersaLink Rod Posterior Offset, 0°, 85 mm The VersaLink Fixation System is a titanium fusion co |
| 07290115931518 | VersaLink Rod Posterior Offset, 0°, 80 mm The VersaLink Fixation System is a titanium fusion co |
| 07290115931501 | VersaLink Rod Posterior Offset, 0°, 75 mm The VersaLink Fixation System is a titanium fusion co |
| 07290115931495 | VersaLink Rod Posterior Offset, 0°, 70 mm The VersaLink Fixation System is a titanium fusion co |
| 07290115931488 | VersaLink Rod Posterior Offset, 0°, 65 mm The VersaLink Fixation System is a titanium fusion co |
| 07290115931419 | VersaLink Rod No Offset, 0°, 85 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931402 | VersaLink Rod No Offset, 0°, 80 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931396 | VersaLink Rod No Offset, 0°, 75 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931389 | VersaLink Rod No Offset, 0°, 70 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931372 | VersaLink Rod No Offset, 0°, 65 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931365 | VersaLink Rod No Offset, 0°, 60 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931358 | VersaLink Rod No Offset, 0°, 55 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931334 | VersaLink Rod No Offset, 0°, 45 mm The VersaLink Fixation System is a titanium fusion construct |
| 07290115931204 | VersaLink Rod Posterior Offset, 15°, 90 mm The VersaLink Fixation System is a titanium fusion c |
| 07290115931198 | VersaLink Rod Posterior Offset, 15°, 85 mm The VersaLink Fixation System is a titanium fusion c |
Trademark Results [VersaLink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSALINK 86695601 5233175 Live/Registered |
XEROX CORPORATION 2015-07-16 |
 VERSALINK 85852430 4851595 Live/Registered |
US LED Ltd. 2013-02-18 |
 VERSALINK 78230883 2900757 Dead/Cancelled |
Datacom Systems, Inc. 2003-03-27 |
 VERSALINK 77854862 3998851 Live/Registered |
Triton Systems of Delaware, LLC 2009-10-22 |
 VERSALINK 76607226 3252144 Dead/Cancelled |
NETGEAR, INC. 2004-08-12 |
VERSALINK 76607226 3252144 Dead/Cancelled |
NETGEAR HOLDINGS LIMITED 2004-08-12 |
 VERSALINK 76279711 not registered Dead/Abandoned |
Jethro, Inc. 2001-07-03 |
 VERSALINK 76279708 not registered Dead/Abandoned |
Jethro, Inc. 2001-07-03 |
 VERSALINK 76061695 not registered Dead/Abandoned |
Osteotech, Inc. 2000-06-02 |
 VERSALINK 74516619 1937916 Live/Registered |
EVONIK DEGUSSA GMBH 1994-04-25 |
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