FDA.reportPublic FDA data

Cancellous Screw 3.8mm

Primary DI
00842188105234
Brand
Cancellous Screw 3.8mm
Company
Trimed, INC.
Model
CAB3.8-14
Catalog number
CAB3.8-14
Device description
Cancellous Screw 3.8, 14mm
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
K251945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251945000TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.2025-07-10HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188105234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188105234008421881052348421881052340842188105234

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
00842188101328Total Wrist Fusion PlatesRFP-STDRFP-STD2016-09-07
00842188101335Total Wrist Fusion PlatesRFP-SHBRFP-SHB2016-09-07
00842188101342Total Wrist Fusion PlatesRFP-STRRFP-STR2016-09-07
00842188105210Cancellous Screw 3.8mmCAB3.8-10CAB3.8-102016-09-07
00842188105227Cancellous Screw 3.8mmCAB3.8-12CAB3.8-122016-09-07
00842188105241Cancellous Screw 3.8mmCAB3.8-16CAB3.8-162016-09-07
00842188105258Cancellous Screw 3.8mmCAB3.8-18CAB3.8-182016-09-07
00842188105265Cancellous Screw 3.8mmCAB3.8-20CAB3.8-202016-09-07
00842188105272Cancellous Screw 3.8mmCAB3.8-22CAB3.8-222016-09-07
00842188105289Cancellous Screw 3.8mmCAB3.8-24CAB3.8-242016-09-07
00842188105296Cancellous Screw 3.8mmCAB3.8-26CAB3.8-262016-09-07
00842188105302Cancellous Screw 3.8mmCAB3.8-28CAB3.8-282016-09-07
00842188105319Cancellous Screw 3.8mmCAB3.8-30CAB3.8-302016-09-07
00842188105326Cancellous Screw 3.8mmCAB3.8-32CAB3.8-322016-09-07
00842188105333Cancellous Screw 3.8mmCAB3.8-34CAB3.8-342016-09-07
00842188105340Cancellous Screw 3.8mmCAB3.8-36CAB3.8-362016-09-07
00842188105357Cancellous Screw 3.8mmCAB3.8-38CAB3.8-382016-09-07
00842188105364Cancellous Screw 3.8mmCAB3.8-40CAB3.8-402016-09-07
00842188121739CannCompScrew 2.3mm (SelfDrill)L2327L23272021-01-11
00842188104404HeadCannCompScrew 3.0mmHL3034HL30342016-09-07

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