FDA.reportPublic FDA data

Anterior Cervical IBFD

Primary DI
B084AC1141609070
Brand
Anterior Cervical IBFD
Company
KEOS
Model
14D x 16W x 09H x 7L, PEEK
Catalog number
AC1-141609-07
Published
2024-02-09
Public version status
New
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212450000Keos Anterior Cervical Interbody Fusion Device SystemKeos2022-06-06ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B084AC1141609070PrimaryHIBCC0

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
080551837
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
B0842003800000Keos Lumbar InstrumentTamp, Straight200-38-00002023-02-10
B0842003800010Keos Lumbar InstrumentTamp, Straight, Bayoneted200-38-00012023-02-10
B0842004100100Keos Lumbar InstrumentGraft Pusher200-41-00102023-02-10
B084AC1141605070Anterior Cervical IBFD14D x 16W x 05H x 7L, PEEKAC1-141605-072024-02-09
B084AC1141606070Anterior Cervical IBFD14D x 16W x 06H x 7L, PEEKAC1-141606-072024-02-09
B084AC1141607070Anterior Cervical IBFD14D x 16W x 07H x 7L, PEEKAC1-141607-072024-02-09
B084AC1141608070Anterior Cervical IBFD14D x 16W x 08H x 7L, PEEKAC1-141608-072024-02-09
B084AC1141610070Anterior Cervical IBFD14D x 16W x 10H x 7L, PEEKAC1-141610-072024-02-09
B084AC1141611070Anterior Cervical IBFD14D x 16W x 11H x 7L, PEEKAC1-141611-072024-02-09
B084AC1141612070Anterior Cervical IBFD14D x 16W x 12H x 7L, PEEKAC1-141612-072024-02-09
B084AC1161805000Anterior Cervical IBFD16D x 18W x 05H x 0L, PEEKAC1-161805-002024-02-09
B084AC1161805040Anterior Cervical IBFD16D x 18W x 05H x 4L, PEEKAC1-161805-042024-02-09
B084AC1161805070Anterior Cervical IBFD16D x 18W x 05H x 7L, PEEKAC1-161805-072024-02-09
B084AC1161806000Anterior Cervical IBFD16D x 18W x 06H x 0L, PEEKAC1-161806-002024-02-09
B084AC1161806040Anterior Cervical IBFD16D x 18W x 06H x 4L, PEEKAC1-161806-042024-02-09
B084AC1161806070Anterior Cervical IBFD16D x 18W x 06H x 7L, PEEKAC1-161806-072024-02-09
B084AC1161807000Anterior Cervical IBFD16D x 18W x 07H x 0L, PEEKAC1-161807-002024-02-09
B084AC1161807040Anterior Cervical IBFD16D x 18W x 07H x 4L, PEEKAC1-161807-042024-02-09
B084AC1161807070Anterior Cervical IBFD16D x 18W x 07H x 7L, PEEKAC1-161807-072024-02-09
B084AC1161808000Anterior Cervical IBFD16D x 18W x 08H x 0L, PEEKAC1-161808-002024-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809986490742BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490759BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490766BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490773BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490780BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490797BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490803BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490810BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490827BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490834BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490841BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490858BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490865BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490872BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490889BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490896BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490902BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490919BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490926BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490933BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490940BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490957BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
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08809986490971BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490988BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
08809986490995BluEX Cervical Expandable Cage SystemL&K BIOMED CO. ,LTD.ODP2026-06-03
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