INNOVERSE Spinal System

GUDID 08800308472217

CG MedTech Co.,Ltd.

Spinal bone screw, non-bioabsorbable
Primary Device ID08800308472217
NIH Device Record Key7389eb5f-94ff-4e8f-8529-c42e24d0e6cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameINNOVERSE Spinal System
Version Model NumberNPA7540PRQ
Company DUNS688811082
Company NameCG MedTech Co.,Ltd.
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 Numbertrue
Manufacturing Datetrue
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
GS108800308472217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


[08800308472217]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-17
Device Publish Date2025-03-09

On-Brand Devices [INNOVERSE Spinal System]

08800037598141NP0260
08800037598134NP0250
08800037598127NP0150
08800247357170NP0110
08800247357446NP0365
08800247357439NP0360
08800247357422NP0355
08800247357415NP0350
08800247357408NP0185
08800247357392NP0180
08800247357385NP0175
08800247357378NP0170
08800247357361NP0030
08800247357248NP0310
08800247357231NP0300
08800247357224NP0290
08800247357217NP0280
08800037598240NP0480
08800037598233NP0470
08800037598226NP0460
08800037598219NP0450
08800037598202NP0440
08800037598196NP0420
08800037598189NP0410
08800308475515NPA6540PSQ
08800308475508NPA6540PSD
08800308475492NPA6540PRQ
08800308475485NPA6540PRD
08800308475478NPA6530PSQ
08800308475461NPA6530PSD
08800308475454NPA6530PRQ
08800308475447NPA6530PRD
08800308475430NPA6060PSQ
08800308475423NPA6060PSD
08800308475416NPA6060PRQ
08800308475409NPA6060PRD
08800308475393NPA6050PSQ
08800308475386NPA6050PSD
08800308475379NPA6050PRQ
08800308475362NPA6050PRD
08800308475355NPA6040PSQ
08800308475348NPA6040PSD
08800308475331NPA6040PRQ
08800308475324NPA6040PRD
08800308475317NPA6030PSQ
08800308475300NPA6030PSD
08800308475294NPA6030PRQ
08800308475287NPA6030PRD
08800308475270NPA5560PSQ
08800308475263NPA5560PSD

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