FDA.reportPublic FDA data

Hex Cortical Screw 3.2mm

Primary DI
00842188106545
Brand
Hex Cortical Screw 3.2mm
Company
Trimed, INC.
Model
HEX3.2-12
Catalog number
HEX3.2-12
Device description
Hex Cortical Screw 3.2, 12mm
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K243987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243987000TriMed Elbow and Forearm SystemTriMed, Inc.2025-03-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188106545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188106545008421881065458421881065450842188106545

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00841731132703REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132710REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132727REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132734REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132758REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
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