FDA.reportPublic FDA data

FMS Screw 5.5mm

Primary DI
00842188107207
Brand
FMS Screw 5.5mm
Company
Trimed, INC.
Model
JHEX5540
Catalog number
JHEX5540
Device description
5th Met Screw 5.5, 40mm
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
K250935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250935000TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)TriMed, Inc.2025-05-22HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188107207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188107207008421881072078421881072070842188107207

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
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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Primary DI, Brand, Company table
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