FDA.reportPublic FDA data

Wireforms

Primary DI
00842188128288
Brand
Wireforms
Company
Trimed, INC.
Model
DBP27-2
Catalog number
DBP27-2
Device description
Dorsal Buttress Pin, 27mm, 2-Hole
Published
2025-02-12
Public version status
Update
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
K243569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243569000TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);TriMed, Inc.2025-01-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188128288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188128288008421881282888421881282880842188128288

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. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a 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 material that is not chemically degraded or absorbed by natural body processes (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
+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
00842188131981CannCompScrew 2.0mm (SelfDrill)L2026L20262026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)L2028L20282026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)L2030L20302026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)L2032L20322026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)L2034L20342026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)L2036L20362026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)L2038L20382026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)L2040L20402026-06-02
00842188132063Tools - HCSHCS-DCADDYHCS-DCADDY2026-06-02
00842188132070Tools - HCSHCS-DCADDYLIDHCS-DCADDYLID2026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131158SledsTrimed, INC.NDL2026-02-19
00842188131165SledsTrimed, INC.NDL2026-02-19
00842188129759K-wiresTrimed, INC.NDL2025-04-23
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
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