FDA.reportPublic FDA data

Lumbar Interbody Fusion System (OLLIF)

Primary DI
00850014575540
Brand
Lumbar Interbody Fusion System (OLLIF)
Company
ADVANCED RESEARCH MEDICAL LLC
Model
01-9080-18T
Catalog number
01-9080-18T
Device description
Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Threaded]
Published
2022-02-03
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173947000Lumbar Interbody Fusion System (OLLIF)Advanced Research Medical, LLC2018-07-25MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014575547PackageGS110In Commercial Distribution
20850014575544PackageGS125In Commercial Distribution
30850014575541PackageGS1100In Commercial Distribution
00850014575540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001457554710850014575547
2085001457554420850014575544
3085001457554130850014575541
00850014575540008500145755408500145755400850014575540

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Diameter1.4Millimeter
Length18Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(612) 440-1865info@advresmed.com

Regulatory Flags#

DUNS number
117201206
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
00850014575038Lumbar Interbody Fusion System (OLLIF)01-200101-20012019-12-16
00850014575076Lumbar Interbody Fusion System (OLLIF)01-271001-27102019-12-16
00850014575083Lumbar Interbody Fusion System (OLLIF)01-271101-27112019-12-16
00850014575090Lumbar Interbody Fusion System (OLLIF)01-271201-27122019-12-16
00850014575106Lumbar Interbody Fusion System (OLLIF)01-271301-27132019-12-16
00850014575113Lumbar Interbody Fusion System (OLLIF)01-271401-27142019-12-16
00850014575120Lumbar Interbody Fusion System (OLLIF)01-271501-27152019-12-16
00850014575144Lumbar Interbody Fusion System (OLLIF)01-300801-30082019-12-16
00850014575151Lumbar Interbody Fusion System (OLLIF)01-300901-30092019-12-16
00850014575168Lumbar Interbody Fusion System (OLLIF)01-301001-30102019-12-16
00850014575175Lumbar Interbody Fusion System (OLLIF)01-301101-30112019-12-16
00850014575182Lumbar Interbody Fusion System (OLLIF)01-301201-30122019-12-16
00850014575199Lumbar Interbody Fusion System (OLLIF)01-301301-30132019-12-16
00850014575205Lumbar Interbody Fusion System (OLLIF)01-301401-30142019-12-16
00850014575212Lumbar Interbody Fusion System (OLLIF)01-301501-30152019-12-16
00850014575229Lumbar Interbody Fusion System (OLLIF)01-331501-33152019-12-16
00850014575236Lumbar Interbody Fusion System (OLLIF)01-331401-33142019-12-16
00850014575243Lumbar Interbody Fusion System (OLLIF)01-331301-33132019-12-16
00850014575250Lumbar Interbody Fusion System (OLLIF)01-331201-33122019-12-16
00850014575267Lumbar Interbody Fusion System (OLLIF)01-331101-33112019-12-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
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