FDA.reportPublic FDA data

Diamond Orthopedic

Primary DI
B551DMDKIT150T10S0
Brand
Diamond Orthopedic
Company
DIAMOND ORTHOPEDIC, LLC
Model
DMD-KIT-150T10-S
Catalog number
DMD-KIT-150T10-S
Device description
Single-Use Instrumentation Kit, T10
Published
2023-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTJGauge, Depth
HTWBit, Drill
HTYPin, Fixation, Smooth
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1
HTWBit, DrillOrthopedic1
HTYPin, Fixation, SmoothOrthopedic2
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B551DMDKIT150T10S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
080596041
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
B551DMDTPS220016S1Diamond OrthopedicDMD-TPS-220-016SDMD-TPS-220-016S2023-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800089487820Surgical InstrumentJeil Medical CorporationHXX2026-10-26
00190776436933MillenniumAvalign Technologies, Inc.HXX2026-10-23
00763000674397MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTW2026-10-23
08059386749203Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2026-10-23
09120125220242Shark Screw® driver cutsurgebright GmbHHXX2026-10-22
00190776435509MillenniumAvalign Technologies, Inc.HTJ2026-10-20
00190776436711MilleniumAvalign Technologies, Inc.HTY2026-10-20
00199150076451Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080373Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080380Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00199150080397Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00824846013600Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-10-19
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HXX2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HXX2026-10-19
05055662968538Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-10-16
04719886913330Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.HTW2026-10-15
04719886915273U-Motion IIUNITED ORTHOPEDIC CORP.HTJ2026-10-15
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
00889795150141APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150158APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150165APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150172APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150189APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150196APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150202APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150219APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150226APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150233APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150240APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12
00889795150257APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HTW2026-10-12