Express IBFD

GUDID B043AV6122500

Advanced Vertebral Solutions, LLC

Polymeric spinal interbody fusion cage
Primary Device IDB043AV6122500
NIH Device Record Key821ef1e7-1e3b-4fcb-94f0-9139ce359e9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameExpress IBFD
Version Model NumberAV6_12250
Company DUNS016610358
Company NameAdvanced Vertebral Solutions, 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 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
HIBCCB043AV6122500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B043AV6122500]

Moist Heat or Steam Sterilization


[B043AV6122500]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-10-22

On-Brand Devices [Express IBFD]

B043AV6173000AV6_17300
B043AV6172500AV6_17250
B043AV6153000AV6_15300
B043AV6152500AV6_15250
B043AV6133000AV6_13300
B043AV6132500AV6_13250
B043AV6123000AV6_12300
B043AV6122500AV6_12250
B043AV6113000AV6_11300
B043AV6112500AV6_11250
B043AV6103000AV6_10300
B043AV6102500AV6_10250
B043AV6093000AV6_09300
B043AV6092500AV6_09250
B043AV6083000AV6_08300
B043AV6082500AV6_08250
B043AV4TI17250C0AV4-Ti_17250C
B043AV4TI15250C0AV4-Ti_15250C
B043AV4TI13250C0AV4-Ti_13250C
B043AV4TI12250C0AV4-Ti_12250C
B043AV4TI11250C0AV4-Ti_11250C
B043AV4TI10250C0AV4-Ti_10250C
B043AV4TI09250C0AV4-Ti_09250C
B043AV4TI08250C0AV4-Ti_08250C
B043AV417250C0AV4_17250C
B043AV415250C0AV4_15250C
B043AV413250C0AV4_13250C
B043AV412250C0AV4_12250C
B043AV411250C0AV4_11250C
B043AV410250C0AV4_10250C
B043AV409250C0AV4_09250C
B043AV408250C0AV4_08250C

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