FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00824846000907
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0426011
Device description
SLAPHAMMER EX0426011 DILATOR
Published
2026-08-16
Public version status
New
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
FZYHAMMER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZYHammer, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00824846000907PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00824846000907008248460009078248460009070824846000907

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation hammering attachmentA surgical instrument designed to be attached to another surgical implantation instrument or directly to an orthopaedic implant to provide a surface on which an operating surgeon can make strikes, with a surgical hammer or mallet, to insert an orthopaedic implant (e.g., an intramedullary nail). It is typically made of high-grade stainless steel and typically in the form of a cylindrical shaft with a threaded portion at the distal end (i.e., threaded into the implant or connected to the implantation instrument) and a broader, robust striking head (surface) at the proximal end. 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
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
00643169190382CLYDESDALE PTC™ Spinal System49268552016-04-17
00643169190399CLYDESDALE PTC™ Spinal System49268502016-04-17
00643169190405CLYDESDALE PTC™ Spinal System49268452016-04-18
00643169190412CLYDESDALE PTC™ Spinal System49268402016-04-17
00643169190429CLYDESDALE PTC™ Spinal System49266602016-04-17
00643169190436CLYDESDALE PTC™ Spinal System49266552016-04-17
00643169190443CLYDESDALE PTC™ Spinal System49266502016-04-17
00643169190450CLYDESDALE PTC™ Spinal System49266452016-04-18
00643169190467CLYDESDALE PTC™ Spinal System49266402016-04-18
00643169190481CLYDESDALE PTC™ Spinal System49264552016-04-18
00643169190504CLYDESDALE PTC™ Spinal System49868602016-04-17
00643169190559CLYDESDALE PTC™ Spinal System49866602016-04-17
00643169190566CLYDESDALE PTC™ Spinal System49866552016-04-17
00643169190573CLYDESDALE PTC™ Spinal System49866502016-04-17
00643169190580CLYDESDALE PTC™ Spinal System49866452016-04-17
00643169190597CLYDESDALE PTC™ Spinal System49866402016-04-17
00643169190603CLYDESDALE PTC™ Spinal System49864602016-04-17
00643169190610CLYDESDALE PTC™ Spinal System49864552016-04-18
00643169190634CLYDESDALE PTC™ Spinal System49864452016-04-17
00643169190658CLYDESDALE PTC™ Spinal System49862602016-04-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093937ELMED INCORPORATEDELMED INCORPORATEDFZY2026-08-18
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03701089527866AMPLITUDEAMPLITUDE SASFZY2026-07-29
10705034647616N/AMedos International SàrlFZY2026-07-09
00198506091179ELMED INCORPORATEDELMED INCORPORATEDFZY2026-06-03
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
00198506089114ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
00198506089411ELMED INCORPORATEDELMED INCORPORATEDFZY2026-04-02
10705034579023N/AMedos International SàrlFZY2026-03-05
00840493416472LUX Expandable Interbody SystemXENIX MEDICAL LLCFZY2026-02-24
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03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
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03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
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03662663244695Vital MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-12-18
04262494463150N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463174N/ADoppkon GmbH & Co. KGFZY2025-12-04
04262494463167N/ADoppkon GmbH & Co. KGFZY2025-11-28
03662663216951Telluride MIS Spinal Fixation SystemHighridge Medical, LLCFZY2025-11-17
03662663267205Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663267601Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
03662663279123Timberline Lateral Fusion SystemHighridge Medical, LLCFZY2025-11-16
00196449034604Anatomic Access LLIFTyber Medical, LLCFZY2025-10-22
00198506085741ELMED INCORPORATEDELMED INCORPORATEDFZY2025-09-19