FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8037101713
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 71-0171R
Catalog number
OM 71-0171R
Device description
K-WIRE S.TROCAR PT.5" .035".9MM
Published
2020-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102845000MAHE FIXATION PLATE AND SCREW SYSTEMMahe Medical GmbH2011-05-13HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8037101713PackageHIBCC6In Commercial Distribution
B803710171R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
503-234-9691SUPPORT@ORTHOMEDINC.COM

Regulatory Flags#

DUNS number
086618626
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B8035903160ORTHOMEDOM 59-03162026-07-22
B8038600980ORTHOMEDOM 86-00982026-07-22
B8038600990ORTHOMEDOM 86-00992026-07-22
B803860120L0ORTHOMEDOM 86-0120L2026-07-22
B8038601250ORTHOMEDOM 86-01252026-07-22
B8039018420ORTHOMEDOM 90-18422026-07-22
B8039018430ORTHOMEDOM 90-18432026-07-22
B8039018840ORTHOMEDOM 90-18842026-07-22
B8039030020ORTHOMEDOM 90-30022026-07-22
B803903220010ORTHOMEDOM 90-3220-012026-07-22
B803903220020ORTHOMEDOM 90-3220-022026-07-22
B8039401000ORTHOMEDOM 94-01002026-07-22
B8039601360ORTHOMEDOM 96-01362026-07-22
B8039601370ORTHOMEDOM 96-01372026-07-22
B8039601390ORTHOMEDOM 96-01392026-07-22
B8039601400ORTHOMEDOM 96-01402026-07-22
B803NL97010ORTHOMEDOM NL97012026-07-22
B803NL9701H0ORTHOMEDOM NL9701-H2026-07-22
B803PW12A0ORTHOMEDOM PW-12A2026-07-22
B803PW14G0ORTHOMEDOM PW-14G2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840536824998PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825001PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825018PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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00840536825032PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825049PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825056PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825063PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825070PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825087PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22