FDA.reportPublic FDA data

Medtronic Resuable Instruments

Primary DI
00643169622265
Brand
Medtronic Resuable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0315069
Device description
PUSHER X0315069 CURV PRONG W/ P HNDL
Published
2022-11-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00643169622265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169622265006431696222656431696222650643169622265

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002139N/A593250132026-07-16
00199150002146N/A593250162026-07-16
00199150015832INFINITY™ Occipitocervical Upper Thoracic System365370252026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic System365370302026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic System365370352026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic System365370402026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic System365370452026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic System365370502026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic System365370552026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic System365370602026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic System365370652026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic System365370702026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic System365370752026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic System365370802026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic System365370852026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic System365370902026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic System365371002026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic System365371102026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic System365371202026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic System365350602026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10603295423324ATTUNEDEPUY (IRELAND)HWA2018-09-24
M684201620111MICROPORTMicroport Orthopedics Inc.HWA2018-09-13
10705034720883NASYNTHES (U.S.A.) LPHWA2018-08-17
10381780408451Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780479406Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-08-16
10381780266389Integra™Allograft Wedge SystemAscension Orthopedics, Inc.HWA2018-04-13
10381780282457Integra® PyroCarbonAscension Orthopedics, Inc.HWA2018-04-13
10381780279495K2™ Hemi Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780279907KGTI™ Kinetik Great Toe Implant SystemAscension Orthopedics, Inc.HWA2018-04-10
10381780224815Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23
10381780224822Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWA2018-03-23