FDA.reportPublic FDA data

Cann. Hex Cortical Screw 3.2mm

Primary DI
00842188129858
Brand
Cann. Hex Cortical Screw 3.2mm
Company
Trimed, INC.
Model
HEX3.2C-08
Catalog number
HEX3.2C-08
Device description
Cannulated Hex Cortical Screw 3.2mm, 8mm
Published
2025-07-22
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
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251134000RipCordTriMed, Inc.2025-07-11HTN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188129858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188129858008421881298588421881298580842188129858

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
00842188132513Tools - ScrewsDVTX-8/085 AO NPDVTX-8/085 AO NP2026-07-09
00842188132520Tools - ScrewsDVTX-8/095 AO NPDVTX-8/095 AO NP2026-07-09
00842188132537Tools - WS3WS3-SCREW-BUWS3-SCREW-BU2026-06-23
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

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