FDA.reportPublic FDA data

MBOSS™ / FIXION™

Primary DI
08904255306639
Brand
MBOSS™ / FIXION™
Company
MERIL HEALTHCARE PRIVATE LIMITED
Model
MT-ST1235012
Device description
3.5mm Locking Screw, Self Tapping (TAN) L12mm - Bone Screws are used for the surgical treatment of fractures, deformities, and tumour diseases of long bones, such as those of the arms and legs. Bone Screws are used for internal fixation and can be used alone to hold a fracture, as well as with plates or nails. Bone Screws are manufactured from Titanium-6Aluminium-7Niobium Alloy (TAN) complies with ISO 5832-11/ASTM F1295, titanium grade 4 (TiCP) complies with ASTM F67 / EN ISO 5832-2 and 18Chromium-14Nickel 2.5Molybdenum Stainless Steel (SS 316L & SS316LVM) complies with ASTM F138 and EN ISO 5832-1
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
K171320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171320000ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION ScrewsMeril Healthcare Pvt. , Ltd.2018-03-08HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904255306639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904255306639089042553066398904255306639

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.

Regulatory Flags#

DUNS number
872346811
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904255306318MBOSS™ / FIXION™MT-ST07270062026-07-22
08904255306332MBOSS™ / FIXION™MT-ST07270082026-07-22
08904255306462MBOSS™ / FIXION™MT-ST07270282026-07-22
08904255306479MBOSS™ / FIXION™MT-ST07270302026-07-22
08904255306486MBOSS™ / FIXION™MT-ST07270322026-07-22
08904255306493MBOSS™ / FIXION™MT-ST07270342026-07-22
08904255306516MBOSS™ / FIXION™MT-ST07270362026-07-22
08904255306523MBOSS™ / FIXION™MT-ST07270382026-07-22
08904255306530MBOSS™ / FIXION™MT-ST07270402026-07-22
08904255306547MBOSS™ / FIXION™MT-ST07270422026-07-22
08904255306554MBOSS™ / FIXION™MT-ST07270442026-07-22
08904255306578MBOSS™ / FIXION™MT-ST07270462026-07-22
08904255306585MBOSS™ / FIXION™MT-ST07270482026-07-22
08904255306592MBOSS™ / FIXION™MT-ST07270502026-07-22
08904255306608MBOSS™ / FIXION™MT-ST07270552026-07-22
08904255306615MBOSS™ / FIXION™MT-ST07270602026-07-22
08904255306622MBOSS™ / FIXION™MT-ST12350102026-07-22
08904255306646MBOSS™ / FIXION™MT-ST12350142026-07-22
08904255306653MBOSS™ / FIXION™MT-ST12350162026-07-22
08904255306660MBOSS™ / FIXION™MT-ST12350182026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22