FDA.reportPublic FDA data

TRABECULAR METAL™

Primary DI
00889024309289
Brand
TRABECULAR METAL™
Company
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Model
00-5452-013-71
Published
2016-06-13
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
HRSPlate, fixation, bone
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102896000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102896000TRABECULAR METAL TIBIAL CONE AUGMENTSZimmer Trabecular Metal Technology2010-12-13MBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024309289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024309289008890243092898890243092890889024309289

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.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
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00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
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00810112593020TriLEAPSynthes GmbHHRS2024-02-22
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00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
00810112593068TriLEAPSynthes GmbHHRS2024-02-22
00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22