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
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
00842078125724CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02