FDA.reportPublic FDA data

TM Ardis®

Primary DI
00889024320543
Brand
TM Ardis®
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
96-701-10001
Catalog number
96-701-10001
Published
2016-05-26
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
K113561000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113561000TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATIONZimmer Trabecular Metal Technology2012-05-29MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024320543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024320543008890243205438890243205430889024320543

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
793120965
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024310810NEXGEN®00-5887-056-0000-5887-056-002016-06-20
00889024223752TM Ardis®96-701-0107196-701-010712016-05-26
00889024223769TM Ardis®96-701-0207196-701-020712016-05-26
00889024223776TM Ardis®96-701-0307196-701-030712016-05-26
00889024223783TM Ardis®96-701-0407196-701-040712016-05-26
00889024223790TM Ardis®96-701-0507196-701-050712016-05-26
00889024223806TM Ardis®96-701-0607196-701-060712016-05-26
00889024223813TM Ardis®96-701-3100196-701-310012016-05-26
00889024316164Mergence™-S96-101-0105196-101-010512017-09-20
00889024316171Mergence™-S96-101-0106196-101-010612017-09-20
00889024316188Mergence™-S96-101-0107196-101-010712017-09-20
00889024316195Mergence™-S96-101-0108196-101-010812017-09-20
00889024316201Mergence™-S96-101-0109196-101-010912017-09-20
00889024316218Mergence™-S96-101-0110196-101-011012017-09-20
00889024316256Mergence™-S96-101-0205196-101-020512017-09-20
00889024316263Mergence™-S96-101-0206196-101-020612017-09-20
00889024316270Mergence™-S96-101-0207196-101-020712017-09-20
00889024316287Mergence™-S96-101-0208196-101-020812017-09-20
00889024316294Mergence™-S96-101-0209196-101-020912017-09-20
00889024316300Mergence™-S96-101-0210196-101-021012017-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14