FDA.reportPublic FDA data

K-wires

Primary DI
00842188129759
Brand
K-wires
Company
Trimed, INC.
Model
WIRE-0.7/100
Catalog number
WIRE-0.7/100
Device description
K-Wire 0.7, 100mm
Published
2025-04-23
Public version status
New
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
NDLPIN, FIXATION, SMOOTH, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDLPin, Fixation, Smooth, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243943000TriMed® Compression ScrewsTriMed, Inc.2025-04-10HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188129759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188129759008421881297598421881297590842188129759

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
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188131288Tools-WFSWFS-CAB3.8WFS-CAB3.82026-05-13
00842188131172Tools - EFSGDOSLEDW-2.3-WGDOSLEDW-2.3-W2026-02-19
00842188131127Tools - WS3WS3-LONGPLATEWS3-LONGPLATE2026-01-28
00842188131134Tools - WS3WS3-LONGPLATE-LIDWS3-LONGPLATE-LID2026-01-28
00842188129773Tools - AFSAFS-HEX3.2CAFS-HEX3.2C2025-07-22
00842188132469Tools- WS3HNDL-TRQ14HNDL-TRQ142026-03-25
00842188131158SledsOSN-W-50OSN-W-502026-02-19
00842188131165SledsOSN-W-70OSN-W-702026-02-19
00842188130564Volar Bearing PlatesVBEAR-13-7SVBEAR-13-7S2026-01-28
00842188110207Generic InstrumentsIMPCT-SLEDIMPCT-SLED2016-09-07
00842188110214Generic InstrumentsSLED-IMPACTRSLED-IMPACTR2016-09-07
00842188111327Tools - FMSIMPCT-FMSIMPCT-FMS2016-09-07
00842188111334Tools - FMSMINI-IMPACTRMINI-IMPACTR2016-09-07
00842188113185Tools - TSSIMPCT-STPLIMPCT-STPL2016-09-07
00842188113192Tools - TSSSTPL-IMPACTRSTPL-IMPACTR2016-09-07
00842188113383Tools - WFSIMPCTIMPCT2016-09-07
00842188113390Tools - WFSIMPACTRIMPACTR2016-09-07
00842188113635Tools - WFSIMPCT-WHVIMPCT-WHV2016-09-07
00842188113642Tools - WFSWHV-IMPACTRWHV-IMPACTR2016-09-07
00842188113659Tools - WFSIMPCT-WHDIMPCT-WHD2016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131158SledsTrimed, INC.NDL2026-02-19
00842188131165SledsTrimed, INC.NDL2026-02-19
00842188128233WireformsTrimed, INC.NDL2025-02-12
00842188128240WireformsTrimed, INC.NDL2025-02-12
00842188128257WireformsTrimed, INC.NDL2025-02-12
00842188128264WireformsTrimed, INC.NDL2025-02-12
00842188128271WireformsTrimed, INC.NDL2025-02-12
00842188128288WireformsTrimed, INC.NDL2025-02-12
00842188128295WireformsTrimed, INC.NDL2025-02-12
00842188129735WireformsTrimed, INC.NDL2025-02-12
00842188125348WireformsTrimed, INC.NDL2023-01-05
00842188125355WireformsTrimed, INC.NDL2023-01-05
00842188119859Generic InstrumentsTrimed, INC.NDL2019-07-26
00842188109041SledsTrimed, INC.NDL2016-09-07
00842188109058SledsTrimed, INC.NDL2016-09-07
00842188109065SledsTrimed, INC.NDL2016-09-07
00842188109072SledsTrimed, INC.NDL2016-09-07
00842188109089SledsTrimed, INC.NDL2016-09-07
00842188109096SledsTrimed, INC.NDL2016-09-07
00842188109102WireformsTrimed, INC.NDL2016-09-07
00842188109119WireformsTrimed, INC.NDL2016-09-07
00842188109126WireformsTrimed, INC.NDL2016-09-07
00842188109133WireformsTrimed, INC.NDL2016-09-07
00842188109140WireformsTrimed, INC.NDL2016-09-07
00842188109157WireformsTrimed, INC.NDL2016-09-07
00842188109164WireformsTrimed, INC.NDL2016-09-07
00842188109171WireformsTrimed, INC.NDL2016-09-07
00842188109188WireformsTrimed, INC.NDL2016-09-07
00842188109195WireformsTrimed, INC.NDL2016-09-07
00842188109201WireformsTrimed, INC.NDL2016-09-07