Rod Transition Set

GUDID 00190837013905

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837013905
NIH Device Record Keyee7dbbda-e20e-4030-8a5e-90627aa1cfea
Commercial Distribution StatusIn Commercial Distribution
Brand NameRod Transition Set
Version Model Number136-540
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
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
GS100190837013905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837013905]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-16

On-Brand Devices [Rod Transition Set]

00190837014063136-155-235
00190837014056136-155-215
00190837014049136-135-235
00190837014032136-135-195
00190837014025136-135-185
00190837014018136-655
00190837014001136-650
00190837013998136-645
00190837013981136-640
00190837013974136-635
00190837013967136-630
00190837013950136-625
00190837013943136-620
00190837013936136-440
00190837013929136-430
00190837013912136-420
00190837013905136-540
00190837013899136-530
00190837013882136-520
00190837013875136-355
00190837013868136-335
00190837013851136-300
00190837013844136-255
00190837013837136-235
00190837013820136-200
00190837013813136-155-225
00190837013806136-135-225
00190837013790136-102
00190837013783136-100
00190837062507136-735-185
00190837062491136-700
00190837062484136-600
00190837062477136-500
00190837062460136-400
00190837062453136-1300R
00190837062446136-1300L
00190837062439136-1125R
00190837062422136-1125L
00190837062415136-1035R
00190837062408136-1035L
00190837062392136-103
00190837062385U - Connector Caddy
001908370623783.5mm-3.5mm Implant Caddy
001908370623615.5mm-5.5mm Implant Caddy
001908370623543.5mm-5.5mm Implant Caddy
00190837062347Rod to Rod Connector Inserter
00190837062330Transition Set Supplement Tray Base
00190837062323Transition Set Supplement Tray Top
00190837062316Transition Set Supplement Tray Lid
00190837062309Transition Tray Base

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