FDA.reportPublic FDA data

Idys™- LIF

Primary DI
03700780600168
Brand
Idys™- LIF
Company
CLARIANCE
Model
04522012-S
Catalog number
04522012-S
Device description
PLIF CAGE
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K131178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131178000IDYS LIF CAGESClariance2013-10-10MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700780600168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700780600168037007806001683700780600168

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20Millimeter
Height12Millimeter
Width11Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7738687041s.chambat@clariance-spine.us

Regulatory Flags#

DUNS number
296568400
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700780640195Idys®-ALIF ZP 3DTi45721000457210002026-07-28
03700780654611Idys®-ALIF ZP 3DTi45710003457100032026-07-28
03700780634583Erisma®-LP18710039187100392026-05-28
03700780643554Erisma®-LP15742006157420062026-02-26
03700780600120Idys™- LIF04522008-S04522008-S2015-10-22
03700780600137Idys™- LIF04522009-S04522009-S2015-10-22
03700780600175Idys™- LIF04522013-S04522013-S2015-10-22
03700780600182Idys™- LIF04522508-S04522508-S2015-10-22
03700780600199Idys™- LIF04522509-S04522509-S2015-10-22
03700780600212Idys™- LIF04522011-S04522011-S2015-10-22
03700780600229Idys™- LIF04522512-S04522512-S2015-10-22
03700780600243Idys™- LIF04522514-S04522514-S2015-10-22
03700780600267Idys™- LIF04522809-S04522809-S2015-10-22
03700780600274Idys™- LIF04522810-S04522810-S2015-10-22
03700780600281Idys™- LIF04522811-S04522811-S2015-10-22
03700780600298Idys™- LIF04522812-S04522812-S2015-10-22
03700780600311Idys™- LIF04522814-S04522814-S2015-10-23
03700780600335Idys™- LIF04523209-S04523209-S2015-10-23
03700780600342Idys™- LIF04523210-S04523210-S2015-10-23
03700780600359Idys™- LIF04523211-S04523211-S2015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00193982141097HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141103HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141110HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141127HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141134HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141141HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141158HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141165HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141172HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141189HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141196HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
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00193982141240HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141257HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141264HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141271HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141288HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141295HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141301HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141318HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141325HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141332HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14