SPINENET ACC®

GUDID B047CL1012070

10mmx12mmx7mm

SPINENET, LLC

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDB047CL1012070
NIH Device Record Key23d2c9bf-da34-4951-bb2a-d64a7cf6d4a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINENET ACC®
Version Model NumberCL101207
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 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 Dimensions

Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter
Length10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB047CL1012070 [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

[B047CL1012070]

Moist Heat or Steam Sterilization


[B047CL1012070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-05

On-Brand Devices [SPINENET ACC®]

B047CTL1214100Trial 12mmx14mmx10mm
B047CTL1214090Trial 12mmx14mmx9mm
B047CTL1214080Trial 12mmx14mmx8mm
B047CTL1214070Trial 12mmx14mmx7mm
B047CTL1214060Trial 12mmx14mmx6mm
B047CTL1214050Trial 12mmx14mmx5mm
B047CTL1012100Trial 10mmx12mmx10mm
B047CTL1012090Trial 10mmx12mmx9mm
B047CTL1012080Trial 10mmx12mmx8mm
B047CTL1012070Trial 10mmx12mmx7mm
B047CTL1012060Trial 10mmx12mmx6mm
B047CTL1012050Trial 10mmx12mmx5mm
B047CL121410012mmx14mmx10mm
B047CL121409012mmx14mmx9mm
B047CL121408012mmx14mmx8mm
B047CL121407012mmx14mmx7mm
B047CL121406012mmx14mmx6mm
B047CL121405012mmx14mmx5mm
B047CL101210010mmx12mmx10mm
B047CL101209010mmx12mmx9mm
B047CL101208010mmx12mmx8mm
B047CL101207010mmx12mmx7mm
B047CL101206010mmx12mmx6mm

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