FDA.reportPublic FDA data

Diamond Orthopedic

Primary DI
B551DMD314430D15
Brand
Diamond Orthopedic
Company
DIAMOND ORTHOPEDIC, LLC
Model
DMD-314-430D-15
Catalog number
DMD-314-430D-15
Device description
Screwdriver, T15, Cannulated, Single Use
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B551DMD314430D15PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
704-585-8270info@diamondortho.com

Regulatory Flags#

DUNS number
080596041
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B551DMD292618Diamond OrthopedicDMD-292-618DMD-292-6182023-11-02
B551DMD292624Diamond OrthopedicDMD-292-624DMD-292-6242023-11-02
B551DMD292721Diamond OrthopedicDMD-292-721DMD-292-7212023-11-02
B551DMDKIT125T05S0Diamond OrthopedicDMD-KIT-125T05-SDMD-KIT-125T05-S2023-11-02
B551DMDKIT150T10S0Diamond OrthopedicDMD-KIT-150T10-SDMD-KIT-150T10-S2023-11-02
B551DMDKIT150T15S0Diamond OrthopedicDMD-KIT-150T15-SDMD-KIT-150T15-S2023-11-02
B551DMD02226210S1Diamond OrthopedicDMD-02-226-210SDMD-02-226-210S2023-11-02
B551DMD02226212S1Diamond OrthopedicDMD-02-226-212SDMD-02-226-212S2023-11-02
B551DMD02226214S1Diamond OrthopedicDMD-02-226-214SDMD-02-226-214S2023-11-02
B551DMD02226216S1Diamond OrthopedicDMD-02-226-216SDMD-02-226-216S2023-11-02
B551DMD02226318S1Diamond OrthopedicDMD-02-226-318SDMD-02-226-318S2023-11-02
B551DMD02226320S1Diamond OrthopedicDMD-02-226-320SDMD-02-226-320S2023-11-02
B551DMD02226322S1Diamond OrthopedicDMD-02-226-322SDMD-02-226-322S2023-11-02
B551DMD02226324S1Diamond OrthopedicDMD-02-226-324SDMD-02-226-324S2023-11-02
B551DMD02226326S1Diamond OrthopedicDMD-02-226-326SDMD-02-226-326S2023-11-02
B551DMD02226328S1Diamond OrthopedicDMD-02-226-228SDMD-02-226-228S2023-11-02
B551DMD02226330S1Diamond OrthopedicDMD-02-226-330SDMD-02-226-330S2023-11-02
B551DMDTPS220010S1Diamond OrthopedicDMD-TPS-220-010SDMD-TPS-220-010S2023-11-02
B551DMDTPS220012S1Diamond OrthopedicDMD-TPS-220-012SDMD-TPS-220-012S2023-11-02
B551DMDTPS220014S1Diamond OrthopedicDMD-TPS-220-014SDMD-TPS-220-014S2023-11-02

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03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
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10887587078557NASynthes GmbHHXX2026-07-24
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