FDA.reportPublic FDA data

LLIF Interbody System

Primary DI
00195860007327
Brand
LLIF Interbody System
Company
Evolution Spine LLC
Model
LL07224514
Catalog number
LL07224514
Device description
22x45x14mm LLIF Cage 7 Deg Lordotic
Published
2021-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195860007327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195860007327001958600073271958600073270195860007327

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
Angle7degree
Depth45Millimeter
Height14Millimeter
Width22Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(214)682-8536info@evolutionspine.com

Regulatory Flags#

DUNS number
116940934
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195860023112EMERGE Anterior Cervical Plate System100-A068100-A0682023-08-21
00195860014042EMERGE Anterior Cervical Plate System100-A024100-A0242021-11-01
00195860014059EMERGE Anterior Cervical Plate System100-A025100-A0252021-11-01
00195860010457Skye Cervical Plate SystemCP-1007CP-10072021-06-02
00195860031803E3D-C Interbody System130-A129130-A1292026-02-20
00195860031810E3D-C Interbody System130-A130130-A1302026-02-20
00195860031827E3D-C Interbody System130-A131130-A1312026-02-20
00195860031834E3D-C Interbody System130-A132130-A1322026-02-20
00195860031841E3D-C Interbody System130-A133130-A1332026-02-20
00195860031858E3D-C Interbody System130-A134130-A1342026-02-20
00195860031865E3D-C Interbody System130-A135130-A1352026-02-20
00195860031872E3D-C Interbody System130-A136130-A1362026-02-20
00195860031889E3D-C Interbody System130-A137130-A1372026-02-20
00195860031896E3D-C Interbody System130-A138130-A1382026-02-20
00195860031902E3D-C Interbody System130-A139130-A1392026-02-20
00195860031919E3D-C Interbody System130-A140130-A1402026-02-20
00195860031926E3D-C Interbody System130-A141130-A1412026-02-20
00195860031933E3D-C Interbody System130-A142130-A1422026-02-20
00195860031940E3D-C Interbody System130-A143130-A1432026-02-20
00195860031957E3D-C Interbody System130-A144130-A1442026-02-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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