Pro-Link Instruments 2019-0006

GUDID 00190837032173

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837032173
NIH Device Record Keye89da84f-2a2c-4d68-94d1-188010189329
Commercial Distribution StatusIn Commercial Distribution
Brand NamePro-Link Instruments
Version Model Number2019-0006
Catalog Number2019-0006
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837032173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837032173]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

Devices Manufactured by Life Spine, Inc.

00190837175214 - ARx SAI2024-12-16
00190837175177 - ARx SAI2024-12-12
00190837175191 - ARx SAI2024-12-12
00190837175238 - ARx SAI2024-12-12
00190837175382 - ARx SAI2024-12-12
00190837153410 - TruLift Lateral2024-10-25
00190837142209 - ProLift2024-10-18
00190837142278 - ProLift2024-10-18

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