FDA.reportPublic FDA data

NA

Primary DI
10887587036236
Brand
NA
Company
Synthes GmbH
Model
311.21.98
Catalog number
3112198
Device description
TAP FOR 2.0MM CORTEX SCREWS 100MM/38MM TAPPING DEPTH
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150796000Dental Bone Cutting InstrumentsSynthes (USA) Products, LLC2015-06-23DZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886982187307Direct MarkingGS10
10887587036236PrimaryGS10
H98031121980SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088698218730710886982187307
1088758703623610887587036236

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, single-useA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a single-use 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
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982239297NA519.51519512017-02-20
10886982195937NA357.2223572222017-02-20
10886982238115NA511.9045119042016-12-31
10886982239358NA519.53519532016-12-31
10886982249043NA60.550.011605500112017-02-20
10886982249104NA60.550.016605500162017-02-20
10886982249135NA60.550.020605500202017-02-20
10886982249142NA60.550.021605500212017-02-20
10886982254917NA690.5946905942017-02-20
10886982362797NASD03.111.915SD031119152026-08-26
10886982362803NASD03.111.916SD031119162026-08-26
10886982362810NASD03.111.917SD031119172026-08-26
10886982362827NASD03.111.918SD031119182026-08-26
10886982362834NASD03.111.919SD031119192026-08-26
10886982362988NASD312.030SD3120302026-08-26
10886982362995NASD312.031SD3120312026-08-26
10886982363008NASD312.032SD3120322026-08-26
10886982363015NASD312.033SD3120332026-08-26
10887587078496NASD03.503.037SD035030372026-08-26
10887587078595NASD03.501.444SD035014442026-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015267801EmbedMed3D LIFEPRINTS UK LTDDZJ2026-03-30
00810007633343AccuPlan SystemMedcadDZJ2025-10-31
00810007633350AccuPlan SystemMedcadDZJ2025-10-31
00810007633367AccuPlan SystemMedcadDZJ2025-10-31
00810007633336AccuPlan System MedcadDZJ2025-10-30
00860012759446TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759453TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759460TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
05420060380747TRUMATCHMaterialise NVDZJ2025-02-28
00810007633183AccuPlan System MedcadDZJ2024-10-18
00810007633190AccuPlan System MedcadDZJ2024-10-18
00810007633213AccuPlan System MedcadDZJ2024-10-18
00810007633220AccuPlan System MedcadDZJ2024-10-18
00810007633237AccuPlan System MedcadDZJ2024-10-18
00860012759408TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759415TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759422TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860011469285TECHFITTechfit Digital Surgery, Inc.DZJ2024-08-28
00860011469261TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469278TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469216TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469223TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469230TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00810007631547AccuPlan SystemMedcadDZJ2023-11-30
00810007632209AccuPlan SystemMedcadDZJ2023-11-02
00810007632223AccuPlan SystemMedcadDZJ2023-11-02
00810007631202AccuPlan System MedcadDZJ2023-11-01
00810007631257AccuPlan System MedcadDZJ2023-11-01
00810007631264AccuPlan SystemMedcadDZJ2023-11-01