FDA.reportPublic FDA data

AUDERE POSTERIOR LUMBAR SPACER SYSTEM

Primary DI
00819824020756
Brand
AUDERE POSTERIOR LUMBAR SPACER SYSTEM
Company
MET 1 TECHNOLOGIES, LLC
Model
30290103
Catalog number
30290103
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
00819824020756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819824020756008198240207568198240207560819824020756

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
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02