FDA.reportPublic FDA data

ATTUNE

Primary DI
10603295423324
Brand
ATTUNE
Company
DEPUY (IRELAND)
Model
2544-01-017
Catalog number
254401017
Device description
ATTUNE IMPACTION HANDLE
Published
2018-09-24
Public version status
New
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
10603295423324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329542332410603295423324

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
10603295170655S-ROM52-15035215032015-09-24
10603295170662S-ROM52-15045215042015-09-24
10603295170679S-ROM52-15055215052015-09-24
10603295170686S-ROM52-15255215252015-09-24
10603295170693S-ROM52-15305215302015-09-24
10603295170709S-ROM52-15355215352015-09-24
10603295170716S-ROM52-15405215402015-09-24
10603295170723S-ROM52-15455215452015-09-24
10603295170730S-ROM52-15525215522015-09-24
10603295170747S-ROM52-15535215532015-09-24
10603295170754S-ROM52-15545215542015-09-24
10603295170761S-ROM52-15555215552015-09-24
10603295175155S-ROM55-02355502352015-09-24
10603295175162S-ROM55-02955502952015-09-24
10603295022435LCS COMPLETE1294-09-3401294093402015-03-24
10603295022442LCS COMPLETE1294-09-3501294093502015-03-24
10603295022459LCS COMPLETE1294-09-3601294093602015-03-24
10603295022466LCS COMPLETE1294-09-3701294093702015-03-24
10603295022756LCS COMPLETE1294-09-8101294098102015-03-24
10603295022763LCS COMPLETE1294-09-8201294098202015-03-24

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
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
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17