FDA.reportPublic FDA data

CannCompScrew 1.7mm (SelfDrill)

Primary DI
00842188128356
Brand
CannCompScrew 1.7mm (SelfDrill)
Company
Trimed, INC.
Model
L1716
Catalog number
L1716
Device description
Self-Drill CCScrew LThd 1.7, 16mm
Published
2025-12-03
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
K243943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243943000TriMed® Compression ScrewsTriMed, Inc.2025-04-10HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188128356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188128356008421881283568421881283560842188128356

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
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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