MBOSS™ / FIXION™ · MT-SS3465095
MERIL HEALTHCARE PRIVATE LIMITED · 6.5mm Cancellous Screw, 16mm Thread Length (SS ) L95mm - Bone Screws are used for the surgical treatment of fractures,…
Open FDA's page for this record- Has donation ID number
- false
- Mri safety
- MR Unsafe
- Record status
- Published
- Is labeled as nrl
- false
- Is rx
- true
- Commercial distribution status
- In Commercial Distribution
- Public device record key
- 1b533f35-fb92-44ce-95c4-b121ff6b53b7
- Has serial number
- true
- Public version date
- 2026-08-03
- Is direct marking exempt
- false
- Public version number
- 1
- Labeler duns number
- 872346811
- Is labeled as no nrl
- false
- Is single use
- true
- Is otc
- false
- Version or model number
- MT-SS3465095
- Has manufacturing date
- true
- Brand name
- MBOSS™ / FIXION™
- Is combination product
- false
- Is kit
- false
- Device count in base package
- 1
- Is pm exempt
- false
- Has lot or batch number
- true
- Company name
- MERIL HEALTHCARE PRIVATE LIMITED
- Public version status
- New
- Has expiration date
- true
- Is hct p
- false
- Publish date
- 2026-07-25
- Device description
6.5mm Cancellous Screw, 16mm Thread Length (SS ) L95mm - 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
- Sterilization
- Is sterile
- false
- Is sterilization prior use
- false
- Identifiers
- ID
- 08904255334557
- Type
- Primary
- Issuing agency
- GS1
- Product codes
- Code
- HWC
- Name
- Screw, Fixation, Bone
- Harmonized identifiers (openFDA)
- Device name
- Screw, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Premarket submissions
- Submission number
- K171320
- Supplement number
- 000
- Gmdn terms
- Code
- 66947
- Name
- Orthopaedic bone screw (non-sliding)
- Implantable
- true
- Code status
- Active
- Definition
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.