FDA.reportPublic FDA data

SmallThreadedIMNail 3.6mm (Ti)

Primary DI
00842188127892
Brand
SmallThreadedIMNail 3.6mm (Ti)
Company
Trimed, INC.
Model
IMN3.6-70 T
Catalog number
IMN3.6-70 T
Device description
Threaded IM Nail 3.6mm, 70mm, Ti
Published
2024-01-22
Public version status
Update
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
K234040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234040000TriMed Threaded Intramedullary Nail SystemTriMed, Inc.2024-01-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188127892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188127892008421881278928421881278920842188127892

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188121739CannCompScrew 2.3mm (SelfDrill)L2327L23272021-01-11
00842188104404HeadCannCompScrew 3.0mmHL3034HL30342016-09-07
00842188131981CannCompScrew 2.0mm (SelfDrill)L2026L20262026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)L2028L20282026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)L2030L20302026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)L2032L20322026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)L2034L20342026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)L2036L20362026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)L2038L20382026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)L2040L20402026-06-02
00842188121678CannCompScrew 1.7mm (SelfDrill)L1707L17072021-01-11
00842188121685CannCompScrew 2.3mm (SelfDrill)L2311L23112021-01-11
00842188121692CannCompScrew 2.3mm (SelfDrill)L2313L23132021-01-11
00842188121708CannCompScrew 2.3mm (SelfDrill)L2315L23152021-01-11
00842188121715CannCompScrew 2.3mm (SelfDrill)L2317L23172021-01-11
00842188121722CannCompScrew 2.3mm (SelfDrill)L2319L23192021-01-11
00842188121746CannCompScrew 3.0mm (SelfDrill)L3011L30112021-01-11
00842188121753CannCompScrew 3.0mm (SelfDrill)L3013L30132021-01-11
00842188121760CannCompScrew 3.0mm (SelfDrill)L3015L30152021-01-11
00842188121777CannCompScrew 3.0mm (SelfDrill)L3017L30172021-01-11

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