FDA.reportPublic FDA data

ORTHOMED

Primary DI
B8037105136R0
Brand
ORTHOMED
Company
ORTHO-MED, INC.
Model
OM 71-0513-6R
Catalog number
OM 71-0513-6R
Device description
"STEIN.PIN S.TROC.RD.6"" 3/32"" (2.4MM)"
Published
2026-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
B8037105136R0PrimaryHIBCC0

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 (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (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 non-bioabsorbable material (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
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
086618626
Device count
1
Lot or batch
true
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
00190776405960MillenniumAvalign Technologies, Inc.HTY2026-07-28
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
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
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
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09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
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07630894830884APTUSMedartis AGHTY2026-06-01
07630894830891APTUSMedartis AGHTY2026-06-01
10888867544571Arthrex®ARTHREX, INC.HTY2026-03-13
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHHTY2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHHTY2025-10-01