SPINENET ACC ®

GUDID B047CGRB1200

SPINENET ACC ® Graft Block-Instrument

SPINENET, LLC

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device IDB047CGRB1200
NIH Device Record Key51aff201-57f2-4c2e-9c92-664b1bf74789
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINENET ACC ®
Version Model NumberCGRB1200
Company DUNS792052321
Company NameSPINENET, LLC
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
HIBCCB047CGRB1200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B047CGRB1200]

Moist Heat or Steam Sterilization


[B047CGRB1200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-10

On-Brand Devices [SPINENET ACC ®]

B047CTRC1400SPINENET ACC ® -Transportation Case
B047CL101205010mmx12mmx5mm
B047CINS1100SpineNet ACC® Inserter Assembly-Instrument
B047CGRP1300SPINENET ACC ® Graft Pusher-Instrument
B047CGRB1200SPINENET ACC ® Graft Block-Instrument

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