FDA.reportPublic FDA data

Diamond Orthopedic, LLC

Primary DI
B551DMD2050340
Brand
Diamond Orthopedic, LLC
Company
DIAMOND ORTHOPEDIC, LLC
Model
DMD-205-034
Catalog number
DMD-205-034
Device description
3.5mm, Cannulated Screw, Partially Thd., 34mm
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B551DMD2050340PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

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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