FDA.reportPublic FDA data

C-STEM

Primary DI
10603295490531
Brand
C-STEM
Company
DEPUY (IRELAND)
Model
2580-00-111
Catalog number
258000111
Device description
C-STEM AMT BROACH SIZE CDH
Published
2022-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBOInstruments designed for press-fit osteochondral implants

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295490531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329549053110603295490531

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810128461495CARTIHEAL AGILI-C Disposable Toolset 7.5T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461501CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461518CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
00840124520493FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2025-05-16
00840124514195PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124514201FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124512825PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512832PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512849PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512856PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512863PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124513853FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00840124513884FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346938Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE Swami Medical, LLCQBO2024-08-22
07290019087199Agili-C Surgical Toolset Full Sterilization TrayCARTIHEAL (2009) LTDQBO2023-12-01
07290019087045Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087052Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087069Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087076Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087083Agili-C Sterilization CaseCARTIHEAL (2009) LTDQBO2022-10-04
07290019087090Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087106Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087113Agili-C Quick Connect Handle CARTIHEAL (2009) LTDQBO2022-10-04
07290019087120Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087137Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087144Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087151Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04