Dyna-Link

GUDID 00190837078607

Life Spine, Inc.

Metallic spinal interbody fusion cage
Primary Device ID00190837078607
NIH Device Record Keyedde38d3-f312-46f7-9c0c-c7870957f12f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDyna-Link
Version Model Number85-655-25
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837078607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


[00190837078607]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-16
Device Publish Date2021-04-08

On-Brand Devices [Dyna-Link]

00190837081935112-210
00190837030292DYNA-LINK Interbody 38mm x 30mm x 19mm, 12°
00190837030285DYNA-LINK Interbody 38mm x 30mm x 19mm, 6°
0019083707860785-655-25
0019083707865285-666-25

Trademark Results [Dyna-Link]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DYNA-LINK
DYNA-LINK
77513261 3674186 Live/Registered
Life Spine, Inc.
2008-07-02

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