FDA.reportPublic FDA data

NA

Primary DI
10887587035512
Brand
NA
Company
Synthes GmbH
Model
310.805
Catalog number
310805
Device description
COUNTERSINK W/CENTERING PINS FOR 2.4MM SCREWS/HEX COUPLING
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
07611819808416Direct MarkingGS10
10887587035512PrimaryGS10
H9803108050SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819808416076118198084167611819808416
1088758703551210887587035512

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. 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
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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840124524255FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
00840124524262FuzeFix Max FTFUSION ORTHOPEDICS, LLCDZJ2025-10-23
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
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
00810007631561AccuPlan SystemMedcadDZJ2023-11-01
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00810007631813AccuPlan System MedcadDZJ2023-11-01
00810007631820AccuPlan System MedcadDZJ2023-11-01
00810007631851AccuPlan System MedcadDZJ2023-11-01
00810007631875AccuPlan System MedcadDZJ2023-11-01
00810007631905AccuPlan System MedcadDZJ2023-11-01
00810007631912AccuPlan System MedcadDZJ2023-11-01
00810007631929AccuPlan System MedcadDZJ2023-11-01
00810007631936AccuPlan System MedcadDZJ2023-11-01