FDA.reportPublic FDA data

Express IBFD

Primary DI
B043AV6152500
Brand
Express IBFD
Company
Advanced Vertebral Solutions, LLC
Model
AV6_15250
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100037000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100037000ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFDAdvanced Vertebral Solutions, LLC2010-09-23MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B043AV6152500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
016610358
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B043AV408250C0Express IBFDAV4_08250C2015-10-22
B043AV409250C0Express IBFDAV4_09250C2015-10-22
B043AV410250C0Express IBFDAV4_10250C2015-10-22
B043AV411250C0Express IBFDAV4_11250C2015-10-22
B043AV412250C0Express IBFDAV4_12250C2015-10-22
B043AV413250C0Express IBFDAV4_13250C2015-10-22
B043AV415250C0Express IBFDAV4_15250C2015-10-22
B043AV417250C0Express IBFDAV4_17250C2015-10-22
B043AV6082500Express IBFDAV6_082502015-10-22
B043AV6083000Express IBFDAV6_083002015-10-22
B043AV6092500Express IBFDAV6_092502015-10-22
B043AV6093000Express IBFDAV6_093002015-10-22
B043AV6102500Express IBFDAV6_102502015-10-22
B043AV6103000Express IBFDAV6_103002015-10-22
B043AV6112500Express IBFDAV6_112502015-10-22
B043AV6113000Express IBFDAV6_113002015-10-22
B043AV6122500Express IBFDAV6_122502015-10-22
B043AV6123000Express IBFDAV6_123002015-10-22
B043AV6132500Express IBFDAV6_132502015-10-22
B043AV6133000Express IBFDAV6_133002015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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