FDA.reportPublic FDA data

Universal2 Total Wrist Implant System

Primary DI
00885556865507
Brand
Universal2 Total Wrist Implant System
Company
Smith & Nephew, Inc.
Model
268660
Catalog number
268660
Device description
POLY IMPACTOR
Published
2023-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00885556865507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556865507008855568655078855568655070885556865507

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
07630055302458Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2020-04-23
07630055302465Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2020-04-23
07640178983052JULIET ® INSTRUMENTATIONSpineArt SAHWA2019-02-01
10705034717364NASynthes GmbHHWA2019-01-18
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24