FDA.reportPublic FDA data

Fuse ULTRA FOOT PLATING SYSTEM

Primary DI
B565OS20160960
Brand
Fuse ULTRA FOOT PLATING SYSTEM
Company
CPM Medical Consultants, LLC
Model
OS2016096
Catalog number
OS2016096
Device description
0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR
Published
2025-05-29
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
HRSPlate, Fixation, Bone
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141784000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141784000ORTHO SOLUTIONS ULTOS PLATING SYSTEMOrtho Solutions Limited2014-07-23HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B565OS20160960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
972-331-5860xx@xx.xx

Regulatory Flags#

DUNS number
017138000
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B565OS328028L1Fuse ULTRA FOOT PLATING SYSTEMOS328028LOS328028L2026-04-17
B565M32205016L1STERIZO Total Knee SystemM-3220-5016LM-3220-5016L2026-02-26
B565M32205016S1STERIZO Total Knee SystemM-3220-5016SM-3220-5016S2026-02-26
B565OS4225081Fuse ULTRA FOOT PLATING SYSTEMOS422508OS4225082025-08-01
B565OS4225101Fuse ULTRA FOOT PLATING SYSTEMOS422510OS4225102025-08-01
B565OS4225121Fuse ULTRA FOOT PLATING SYSTEMOS422512OS4225122025-08-01
B565OS4225141Fuse ULTRA FOOT PLATING SYSTEMOS422514OS4225142025-08-01
B565OS4225161Fuse ULTRA FOOT PLATING SYSTEMOS422516OS4225162025-08-01
B565OS4225181Fuse ULTRA FOOT PLATING SYSTEMOS422518OS4225182025-08-01
B565OS4225201Fuse ULTRA FOOT PLATING SYSTEMOS422520OS4225202025-08-01
B565OS4225221Fuse ULTRA FOOT PLATING SYSTEMOS422522OS4225222025-08-01
B565OS4225241Fuse ULTRA FOOT PLATING SYSTEMOS422524OS4225242025-08-01
B565OS4225261Fuse ULTRA FOOT PLATING SYSTEMOS422526OS4225262025-08-01
B565OS4225281Fuse ULTRA FOOT PLATING SYSTEMOS422528OS4225282025-08-01
B565OS4225301Fuse ULTRA FOOT PLATING SYSTEMOS422530OS4225302025-08-01
B565OS4226081Fuse ULTRA FOOT PLATING SYSTEMOS422608OS4226082025-08-01
B565OS4226101Fuse ULTRA FOOT PLATING SYSTEMOS422610OS4226102025-08-01
B565OS4226121Fuse ULTRA FOOT PLATING SYSTEMOS422612OS4226122025-08-01
B565OS4226141Fuse ULTRA FOOT PLATING SYSTEMOS422614OS4226142025-08-01
B565OS4226161Fuse ULTRA FOOT PLATING SYSTEMOS422616OS4226162025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07630894822902APTUSMedartis AGHRS2026-07-16
07630894822919APTUSMedartis AGHRS2026-07-16
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07630894822933APTUSMedartis AGHRS2026-07-16
07630894822940APTUSMedartis AGHRS2026-07-16
07630894822957APTUSMedartis AGHRS2026-07-16
07630894822964APTUSMedartis AGHRS2026-07-16
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07630894823145APTUSMedartis AGHRS2026-07-16
07630894823152APTUSMedartis AGHRS2026-07-16
07630894823176APTUSMedartis AGHRS2026-07-16
07630894823183APTUSMedartis AGHRS2026-07-16
07630894823206APTUSMedartis AGHRS2026-07-16