FDA.reportPublic FDA data

AUDERE POSTERIOR LUMBAR SPACER SYSTEM

Primary DI
00819824020862
Brand
AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Company
MET 1 TECHNOLOGIES, LLC
Model
30290140
Catalog number
30290140
Device description
THE AUDERE POSTERIOR LUMBAR SPACER SYSTEM CONSISTS OF IMPLANTS, TRIALS, AND INSTRUMENTS. THE AUDERE LUMBAR SPACER SYSTEM MAY BE IMPLANTED BILATERALLY USING A POSTERIOR (PLIF) APPROACH, OR A SINGLE DEVICE EMPLOYING A TRANSFORAMINAL (TLIF) APPROACH.
Published
2017-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K160699000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160699000VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC2016-08-01MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819824020862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824020862008198240208628198240208620819824020862

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic 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 a ceramic material [e.g., silicon nitride] 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

Contacts#

Phone, Email table
PhoneEmail
9154726762yone@ldmedicalprods.com

Regulatory Flags#

DUNS number
080474650
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819824024129CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010012600100122019-03-06
00819824024136CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010014600100142019-03-06
00819824024143CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010016600100162019-03-06
00819824024150CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010018600100182019-03-06
00819824024167CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010020600100202019-03-06
00819824024174CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010022600100222019-03-06
00819824024181CZAR ANTERIOR CERVICAL PLATE SYSTEM 1 LEVEL60010024600100242019-03-06
00819824024198CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020024600200242019-03-06
00819824024204CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020026600200262019-03-06
00819824024211CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020028600200282019-03-06
00819824024228CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020030600200302019-03-06
00819824024235CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020032600200322019-03-06
00819824024242CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020034600200342019-03-06
00819824024259CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020037600200372019-03-06
00819824024266CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020040600200402019-03-06
00819824024273CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020043600200432019-03-06
00819824024280CZAR ANTERIOR CERVICAL PLATE SYSTEM 2 LEVEL60020046600200462019-03-06
00819824024297CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030039600300392019-03-06
00819824024303CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030042600300422019-03-06
00819824024310CZAR ANTERIOR CERVICAL PLATE SYSTEM 3 LEVEL60030045600300452019-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420156NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421207BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30