VertebraLINK MI 84-0651-01

GUDID 00817329024583

MI Inserter - 8mm

LINKSPINE, INC.

Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile Polymeric spinal fusion cage, sterile
Primary Device ID00817329024583
NIH Device Record Key816349ee-a56c-4591-96e9-84f236e969c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertebraLINK MI
Version Model Number84-0651-01
Catalog Number84-0651-01
Company DUNS067584601
Company NameLINKSPINE, 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 Usefalse
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

Customer Support Contacts

Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com
Phone1-410-772-5465
Emailcs@linkspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817329024583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817329024583]

Moist Heat or Steam Sterilization


[00817329024583]

Moist Heat or Steam Sterilization


[00817329024583]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2018-05-29

On-Brand Devices [VertebraLINK MI]

00817329025672VertebraLINK MI Set
00817329024590MI Inserter - 10mm
00817329024583MI Inserter - 8mm
00817329023203MI Inserter Draw Rod
00817329023197Bayonetted Scalpel Handle

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