FDA.reportPublic FDA data

Cann. Hex Cortical Screw 3.2mm

Primary DI
00842188129872
Brand
Cann. Hex Cortical Screw 3.2mm
Company
Trimed, INC.
Model
HEX3.2C-14
Catalog number
HEX3.2C-14
Device description
Cannulated Hex Cortical Screw 3.2mm, 14mm
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
00842188129872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188129872008421881298728421881298720842188129872

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
00842188100758Locking PlatesPC6PC62016-09-07
00842188100765Locking PlatesPCA8PCA82016-09-07
00842188100772Locking PlatesPCA10PCA102016-09-07
00842188100789Locking PlatesPCA15PCA152016-09-07
00842188100796Locking PlatesPCB8PCB82016-09-07
00842188100802Locking PlatesPCB10PCB102016-09-07
00842188100819Locking PlatesPCB15PCB152016-09-07
00842188100826Locking PlatesPS5PS52016-09-07
00842188100833Locking PlatesPS6PS62016-09-07
00842188100840Locking PlatesPS8PS82016-09-07
00842188100857Locking PlatesPS10PS102016-09-07
00842188100864Locking PlatesPS12PS122016-09-07
00842188100871Locking PlatesPS15PS152016-09-07
00842188101274Hook PlatesOHOOK-4OHOOK-42016-09-07
00842188101281Hook PlatesOHOOKL-6OHOOKL-62016-09-07
00842188101298Hook PlatesOHOOKL-8OHOOKL-82016-09-07
00842188101304Hook PlatesOHOOKR-6OHOOKR-62016-09-07
00842188101311Hook PlatesOHOOKR-8OHOOKR-82016-09-07
00842188106514Hex Cortical Screw 3.2mmHEX3.2-08HEX3.2-082016-09-07
00842188106521Hex Cortical Screw 3.2mmHEX3.2-10HEX3.2-102016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00841731132673REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
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00841731132697REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
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00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
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00841731132765REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132772REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132789REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132796REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132802REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132819REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132826REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132833REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132840REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132857REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132864REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132871REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132888REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132895REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132901REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132918REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132925REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132932REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03