FDA.reportPublic FDA data

Lumbar IBFD

Primary DI
B084KPS22308100
Brand
Lumbar IBFD
Company
KEOS
Model
23L x 8W x 10H Straight, HA Enhanced
Catalog number
KPS2-230810
Published
2017-11-30
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
B084KPS22308100PrimaryHIBCC0

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
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520094ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520193ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520209ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520216ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520223ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520230ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520247ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520254ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520261ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520278ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520285ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520292ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10