FDA.reportPublic FDA data

Lumbar IBFD

Primary DI
B084KTC12810090
Brand
Lumbar IBFD
Company
KEOS
Model
28L x 10W x 9H Curved
Catalog number
KTC1-281009
Published
2018-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K160631000
K163386000
K193174000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160631000Keos Lumbar IBFDKeos2016-07-15MAX
K163386000Keos Lumbar IBFDKeos2017-04-10MAX
K193174000Keos Lumbar IBFDKeos2019-12-16MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B084KTC12810090PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B0842000200000Keos Lumbar Case/CaddyImplant Case, Lumbar IBFD System, w/ Lid200-02-00002023-01-30
B0842000200100Keos Lumbar Case/CaddyInstrument Case, Lumbar IBFD System, w/ Lid200-02-00102023-01-30
B0842000200210Keos Lumbar Case/CaddyLid, Lumbar IBFD System200-02-00212023-01-30
B0842000201000Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK200-02-01002023-01-30
B0842000201010Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK200-02-01012023-01-30
B0842000201020Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK200-02-01022023-01-30
B0842000201030Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK200-02-01032023-01-30
B0842000201040Keos Lumbar Case/CaddyCaddy Assy, 23L x 8W, Straight, PEEK HA-Enhanced200-02-01042023-01-30
B0842000201050Keos Lumbar Case/CaddyCaddy Assy, 23L x 10W, Straight, PEEK HA-Enhanced200-02-01052023-01-30
B0842000201060Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Straight, PEEK HA-Enhanced200-02-01062023-01-30
B0842000201070Keos Lumbar Case/CaddyCaddy Assy, 28L x 10W, Curved, PEEK HA-Enhanced200-02-01072023-01-30
B0842000201510Keos Lumbar Case/CaddyCaddy Lid, PEEK200-02-01512023-01-30
B0842000201530Keos Lumbar Case/CaddyCaddy Lid, PEEK HA-Enhanced200-02-01532023-01-30
B0842000202000Keos Lumbar Case/CaddyInstrument Case, Limited Release MPE, w/ Lid200-02-02002023-01-30
B0842000203000Keos Lumbar Case/CaddyAuxiliary Case, w/ Lid200-02-03002023-01-30
B0842002400000Keos Lumbar InstrumentT-Handle, QC, 1/4" Square Adapter200-24-00002023-01-30
B0842002600000Keos Lumbar InstrumentInsertion Handle, Threaded200-26-00002023-01-30
B0842002600100Keos Lumbar InstrumentInsertion Rod, Threaded200-26-00102023-01-30
B0842002700000Keos Lumbar InstrumentInsertion Handle, Clamp200-27-00002023-01-30
B0842002700020Keos Lumbar InstrumentAttachment Knob, Insertion Handle, Clamp200-27-00022023-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
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00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
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00810161900589EARP, 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900619EARP, 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900626EARP, 18X35X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900633EARP, 18X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16