FDA.reportPublic FDA data

SMARTSET

Primary DI
10603295168355
Brand
SMARTSET
Company
DEPUY (IRELAND)
Model
3102-080
Catalog number
3102080
Device description
SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDZMIXER, CEMENT, FOR CLINICAL USE
KIHDISPENSER, CEMENT
LODBONE CEMENT
MBBBONE CEMENT, ANTIBIOTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1
KIHDispenser, CementOrthopedic1
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033382000
K041656000
K042591000
P960001001
P960001005
P960001008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033382000SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTDePuy Orthopaedics, Inc.2004-02-05LOD
K041656000MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENTDePuy Orthopaedics, Inc.2004-07-01LOD
K042591000SMARTMIX PRE-FILLED MIXING SYSTEMDePuy Orthopaedics, Inc.2004-10-22KIH
P960001001DEPUY 1 BONE CEMENTDepuy, Inc.1997-02-11LOD
P960001005DEPUY 1 BONE CEMENTDepuy, Inc.1997-02-11LOD
P960001008DEPUY 1 BONE CEMENTDepuy, Inc.1997-02-11LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20603295168352PackageGS110In Commercial Distribution
30603295168359PackageGS120In Commercial Distribution
10603295168355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060329516835220603295168352
3060329516835930603295168359
1060329516835510603295168355

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Storage Environment Temperature025 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295005438GLOBAL AP1130-02-0001130020002015-09-24
10603295218289S-ROM87-34358734352015-09-24
10603295218470S-ROM87-35568735562015-09-24
10603295218487S-ROM87-35578735572015-09-24
10603295218951S-ROM87-59878759872015-09-24
10603295519935VELYS4515-70-2264515702262021-05-26
10603295519430VELYS4515-70-1024515701022021-05-13
10603295519492VELYS4515-70-1014515701012021-05-13
10603295519515VELYS4515-70-1004515701002021-05-13
10603295519379VELYS4515-70-1074515701072021-05-07
10603295519461VELYS4515-70-1054515701052021-05-07
10603295519478VELYS4515-70-1064515701062021-05-07
10603295519485VELYS4515-70-1094515701092021-05-07
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24

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Primary DI, Brand, Company table
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00840456223635JMUJMU DENTAL, INCJDZ2026-08-18
00840456223642JMUJMU DENTAL, INCJDZ2026-08-18
00840456223659JMUJMU DENTAL, INCJDZ2026-08-18
00840456223789JMUJMU DENTAL, INCJDZ2026-08-18
00840456223796JMUJMU DENTAL, INCJDZ2026-08-18
00840456223802JMUJMU DENTAL, INCJDZ2026-08-18
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08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
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08031497003801Mendec® Kypho Set Bilateral 10 mmTECRES SPAKIH2025-12-17
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08031497003825Mendec® Kypho Set Bilateral 20 mmTECRES SPAKIH2025-12-17
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