FDA.reportPublic FDA data

ATTUNE

Primary DI
10603295041276
Brand
ATTUNE
Company
DEPUY (IRELAND)
Model
1504-00-224
Catalog number
150400224
Device description
ATTUNE KNEE SYSTEM FEMORAL CRUCIATE RETAINING NARROW SIZE 4N RIGHT CEMENTED
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJLProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295041276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329504127610603295041276

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee femur prosthesis, metallicAn implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295503309ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503316ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503323ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503330ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503347ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503354ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503361ATTUNEDEPUY (IRELAND)NJL2026-01-13
10603295503378ATTUNEDEPUY (IRELAND)NJL2026-01-13
00889024665118NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665125NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665132NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665149NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665156NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665163NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665170NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665187NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665194NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665200NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665217NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665224NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665231NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665248NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665255NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665262NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665279NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665286NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665293NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665309NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665316NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05
00889024665323NexGen® Complete Knee SolutionZimmer, Inc.NJL2024-11-05