FDA.reportPublic FDA data

SIGMA

Primary DI
10603295225256
Brand
SIGMA
Company
DEPUY (IRELAND)
Model
9505-01-218
Catalog number
950501218
Device description
SIGMA HIGH PERFORMANCE FEMORAL NOTCH IMPACTOR
Published
2018-09-24
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
HWAIMPACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295225256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329522525610603295225256

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. 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
07640187918816Ortho Development Offset Cup Impactor, 5/16-24 UNF x 3.94MPS Micro Precision Systems AGHWA2026-09-27
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
03701089527934AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527941AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527958AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089528450AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089547512AMPLITUDEAMPLITUDE SASHWA2026-07-29
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
00822409135721N/AOrtho Development CorporationHWA2026-07-16
07630055307781Positioning handle - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307798Positioning handle - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
07630055307804Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
00840286860406Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWA2026-07-09
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
08809885739751PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.HWA2026-01-28
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
00885556865491Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWA2023-01-19
00885556865507Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWA2023-01-19
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
00840096403848Viant Medical, LLCVIANT MEDICALHWA2020-08-08
00840096401172Viant Medical, LLCVIANT MEDICALHWA2020-05-14
00840096401196Viant Medical, LLCVIANT MEDICALHWA2020-05-14