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

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Primary DI, Brand, Company table
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00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
05055662968545OrthoSolutions 'System26' Bone ScrewsORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-06-24
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-06-24
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
06974940307878endophixSuzhou Endophix Co., Ltd.HXX2026-06-23
008401944961003P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944963773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944966433P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
008401944969193P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HXX2026-06-10
00889024707726SolidLok®Biomet Orthopedics, LLCHXX2026-06-10
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10
04052536176700neon3Ulrich GmbH & Co. KGHTW2026-06-08
04052536176717neon3Ulrich GmbH & Co. KGHTW2026-06-08
00196449017355A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017362A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017409A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017416A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017423A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017430A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04
00196449017447A.L.P.S. mvX™Tyber Medical, LLCHTW2026-06-04