FDA.reportPublic FDA data

NA

Primary DI
10603295148555
Brand
NA
Company
DEPUY ORTHOPAEDICS, INC.
Model
2598-07-580
Catalog number
259807580
Device description
TISSUE SPARING SOLUTIONS THREADED SLAP HAMMER ADAPTER
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10603295148555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329514855510603295148555

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. 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
080506581
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
10603295562108VELYS Hip Navigation4515801514515801512026-03-24
10603295553625ATTUNE2999-67-0322999670322026-02-17
10603295553632ATTUNE2999-67-0332999670332026-02-17
10603295553649ATTUNE2999-67-0342999670342026-02-17
10603295553656ATTUNE2999-67-0352999670352026-02-17
10603295554974EMPHASYS2999-67-0462999670462026-02-04
10603295080121AML EXCEL2001-65-0002001650002018-06-15
10603295082408DURALOC2015-24-0002015240002018-09-24
10603295083382SIGMA2024-57-1112024571112018-09-24
10603295084075SIGMA2024-85-0052024850052018-09-24
10603295088042GLOBAL FX2128-01-0222128010222018-09-24
10603295090540GLOBAL AP2130-01-0552130010552018-09-24
10603295090687GLOBAL AP2130-04-0002130040002018-09-24
10603295094005NA2178-30-1222178301222018-09-24
10603295095651LCS COMPLETION2178-60-0282178600282018-09-24
10603295096184NA2178-63-1242178631242018-09-24
10603295096191NA2178-63-1262178631262018-09-24
10603295098935PINNACLE2217-50-0042217500042018-09-24
10603295098942PINNACLE2217-50-0052217500052018-09-24
10603295098959PINNACLE2217-50-0062217500062018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189451162Surgical DesignSurgical Design, Inc.FZY2026-05-23
00810189451483Surgical DesignSurgical Design, Inc.FZY2026-05-23
10705034579023N/AMedos International SàrlFZY2026-03-05
03662663083638ActivLHighridge Medical, LLCFZY2026-02-03
03662663083645ActivLHighridge Medical, LLCFZY2026-02-03
03662663083652ActivLHighridge Medical, LLCFZY2026-02-03
03662663083669ActivLHighridge Medical, LLCFZY2026-02-03
03662663083676ActivLHighridge Medical, LLCFZY2026-02-03
03662663083690ActivLHighridge Medical, LLCFZY2026-02-03
03662663155618Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155762Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
03662663155779Zyston Interbody Spacer SystemHighridge Medical, LLCFZY2025-12-29
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
04059453096517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHFZY2025-08-25
04262494460562N/ADoppkon GmbH & Co. KGFZY2025-08-05
10889981322144REEF LSeaspine Orthopedics CorporationFZY2025-07-15
00199150021550Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.FZY2025-07-13
00840019959766ShurFit Lumbar InterbodyPRECISION SPINE, INC.FZY2025-05-29
00840194472371PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840194472388PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840194472395PNP FemurORTHOPEDIATRICS CORP.FZY2025-05-28
00840286841597Consensus Hip System/UniSyn Hip SystemShalby Advanced Technologies, Inc.FZY2025-05-22
00840286845588Consensus Knee SystemShalby Advanced Technologies, Inc.FZY2025-05-21