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
00842188132452Tools - TWFNSF-CADDY-LIDNSF-CADDY-LID2026-08-18
00842188127014Tools - FMSFMS-TRAY-LIDFMS-TRAY-LID2023-04-19
00842188100437Foot PlatesSP20-3SSP20-3S2016-09-07
00842188100444Foot PlatesSP20-3MSP20-3M2016-09-07
00842188100451Foot PlatesSP20-4SP20-42016-09-07
00842188100468Foot PlatesSP20-6SP20-62016-09-07
00842188100475Foot PlatesTP20-5TP20-52016-09-07
00842188100482Foot PlatesTP20-7TP20-72016-09-07
00842188100888Locking PlatesBRGPBRGP2016-09-07
00842188100949Hook PlatesMHOOK-5MHOOK-52016-09-07
00842188100956Hook PlatesMHOOK-7MHOOK-72016-09-07
00842188101526Osteotomy Compression PlatesUOCPUOCP2016-09-07
00842188101533Osteotomy Compression PlatesUOCP-SUOCP-S2016-09-07
00842188105425FPS Locking Screw 2.0mmCLS2.0-06CLS2.0-062016-09-07
00842188105432FPS Locking Screw 2.0mmCLS2.0-08CLS2.0-082016-09-07
00842188105449FPS Locking Screw 2.0mmCLS2.0-10CLS2.0-102016-09-07
00842188105456FPS Locking Screw 2.0mmCLS2.0-12CLS2.0-122016-09-07
00842188105463FPS Locking Screw 2.0mmCLS2.0-14CLS2.0-142016-09-07
00842188105470FPS Locking Screw 2.0mmCLS2.0-16CLS2.0-162016-09-07
00842188105487FPS Locking Screw 2.0mmCLS2.0-18CLS2.0-182016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132575SledsTrimed, INC.NDL2026-07-24
00842188132582SledsTrimed, INC.NDL2026-07-24
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