FDA.reportPublic FDA data

Locking Compression Screw 2.4mm

Primary DI
00842188108204
Brand
Locking Compression Screw 2.4mm
Company
Trimed, INC.
Model
NC2420
Catalog number
NC2420
Device description
Compression Screw 2.4, 20mm
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
K250948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250948000TriMed Fusion Cup SystemTriMed, Inc.2025-04-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188108204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188108204008421881082048421881082040842188108204

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
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
00842188119712Torx Smooth PegSPEG1.8-14SPEG1.8-142019-05-07
00842188119729Torx Smooth PegSPEG1.8-16SPEG1.8-162019-05-07
00842188119736Torx Smooth PegSPEG1.8-18SPEG1.8-182019-05-07
00842188119743Torx Smooth PegSPEG1.8-20SPEG1.8-202019-05-07
00842188119750Torx Smooth PegSPEG1.8-22SPEG1.8-222019-05-07
00842188100000Pin PlatesDUP3DUP32016-09-07
00842188100017Pin PlatesDUP5DUP52016-09-07
00842188100024Pin PlatesDUP7DUP72016-09-07
00842188100031Peg PlatesUPG-5UPG-52016-09-07
00842188100048Peg PlatesUPG-7UPG-72016-09-07
00842188100055Pin PlatesRCP3RCP32016-09-07
00842188100062Pin PlatesRCP5RCP52016-09-07
00842188100079Pin PlatesRCP7RCP72016-09-07
00842188100086Peg PlatesRPGL-7RPGL-72016-09-07
00842188100093Peg PlatesRPGR-7RPGR-72016-09-07
00842188100109Peg PlatesRPGL-10RPGL-102016-09-07
00842188100116Peg PlatesRPGR-10RPGR-102016-09-07
00842188100727Fusion CupsFC07FC072016-09-07
00842188100734Fusion CupsFC10FC102016-09-07
00842188100741Fusion CupsLFC10LFC102016-09-07

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