FDA.reportPublic FDA data

SIGMA

Primary DI
10603295501855
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
1024-56-307
Catalog number
102456307
Device description
SIGMA HIGH PERFORMANCE PARTIAL KNEE TIBIAL INSERT FIXED BEARING UNICONDYLAR SIZE 3 RM/LL 7MM
Published
2021-04-23
Public version status
New
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
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
OIYProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2
OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + AdditiveOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193549000SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC2020-04-16HRY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295501855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329550185510603295501855

Sterilization Methods#

Method table
Method

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
10603295518761SMARTSET5450-45-5005450455002026-09-10
10603295168324SMARTSET3092-02030920202015-09-24
10603295168331SMARTSET3092-04030920402015-09-24
10603295168355SMARTSET3102-08031020802015-09-24
10603295168362SMARTSET3122-02031220202015-09-24
10603295168379SMARTSET3122-04031220402015-09-24
10603295168614NA3312-04033120402015-09-24
10603295168621NA3322-02033220202015-09-24
10603295168638NA3332-04033320402015-09-24
10603295174264NA5450-31-5005450315002015-09-24
10603295174271NA5450-32-5005450325002015-09-24
10603295174288SMARTSET5450-35-5005450355002015-09-24
10603295174295SMARTSET5450-50-5015450505012015-09-24
10603295202486SMARTMIX CEMVAC83-16038316032018-09-24
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629475007EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475014EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475021EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475038EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475045EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475052EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475069EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475076EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475083EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475090EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475106EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475113EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475120EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475137EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475144EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475151EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475168EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475175EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475182EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475199EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475205EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475212EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475229EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475236EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475243EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475250EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475267EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475274EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475281EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03
00192629475298EVOLUTIONMicroport Orthopedics Inc.HRY2026-11-03