FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8037103073
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 71-0307R
Catalog number
OM 71-0307R
Device description
K-WIRE S.DMD.THR. 9".062" 1.6MM
Published
2020-05-18
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B8037103073PackageHIBCC6In Commercial Distribution
B803710307R0PrimaryHIBCC0

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
B803904210SS0ORTHOMEDOM 90-4210-SSOM 90-4210-SS2026-05-08
B8037105136R0ORTHOMEDOM 71-0513-6ROM 71-0513-6R2026-05-01
B803KWIRE10C150S0ORTHOMEDKWIRE-10C-150SKWIRE-10C-150S2026-05-01
B8034802690ORTHOMEDOM 18-02692026-04-16
B8034803200ORTHOMEDOM 48-03202026-04-16
B8034803220ORTHOMEDOM 48-03222026-04-16
B8034803240ORTHOMEDOM 48-03242026-04-16
B8034803700ORTHOMEDOM 48-03702026-04-16
B8034803720ORTHOMEDOM 48-03722026-04-16
B8034803860ORTHOMEDOM 48-03862026-04-16
B8034803880ORTHOMEDOM 48-03882026-04-16
B8035202080ORTHOMEDOM 52-02082026-04-16
B8035202120ORTHOMEDOM 52-02122026-04-16
B8035202140ORTHOMEDOM 52-02142026-04-16
B8035202160ORTHOMEDOM 52-02162026-04-16
B8035202540ORTHOMEDOM 52-02542026-04-16
B8035202580ORTHOMEDOM 52-02582026-04-16
B8035202620ORTHOMEDOM 52-02622026-04-16
B8035202640ORTHOMEDOM 52-02642026-04-16
B8035202660ORTHOMEDOM 52-02662026-04-16

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07649990202389Handle SSurgical Fusion Technologies GmbHHTY2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHHTY2025-10-01
07630037863977APTUSMedartis AGHTY2025-07-31
07630037863984APTUSMedartis AGHTY2025-07-31
07630037864011APTUSMedartis AGHTY2025-04-08
07630037864264APTUSMedartis AGHTY2025-04-08
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07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202297Guide S-PI / W5.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHHTY2024-04-12
07649990202310Drill S-PI-A1.6Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202327Drill S-PI-A2.3Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202334Drill S-PI-A3.0Surgical Fusion Technologies GmbHHTY2024-04-12
07649990202365Tray SF Push-in Anchor PortfolioSurgical Fusion Technologies GmbHHTY2024-04-12
07630037863854APTUSMedartis AGHTY2024-03-22
07630037863915APTUSMedartis AGHTY2024-03-22
07630037864196APTUSMedartis AGHTY2024-03-22
07630037864226APTUSMedartis AGHTY2024-03-22
07630037864233APTUSMedartis AGHTY2024-03-22
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHHTY2024-02-06
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