FDA.reportPublic FDA data

Medical Facets NC

Primary DI
M933MDF022260100
Brand
Medical Facets NC
Company
MEDICAL FACETS NC LLC
Model
MDF02226010
Catalog number
MDF02226010
Device description
3.0mm Headless Compression Screw, Short Thread, 10mm
Published
2015-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M933MDF022260100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterile"A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression. This device must be sterilized prior to use."

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
704-215-5375customerservice@medscrews.com

Regulatory Flags#

DUNS number
061276724
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M933MDF022260110Medical FacetsMDF02226011MDF022260112015-10-12
M933MDF022260120Medical Facets NCMDF-02-226-012MDF-02-226-0122015-10-09
M933MDF022260130Medical Facets NCMDF-02-226-013MDF-02-226-0132015-10-09
M933MDF022260140Medical Facets NCMDF-02-226-014MDF-02-226-0142015-10-09
M933MDF022260150Medical Facets NCMDF-02-226-015MDF-02-226-0152015-10-09
M933MDF022260160Medical Facets NCMDF-02-226-016MDF-02-226-0162015-10-09
M933MDF022260170Medical Facets NCMDF-02-226-017MDF-02-226-0172015-10-09
M933MDF022260180Medical Facets NCMDF-02-226-018MDF-02-226-0182015-10-09
M933MDF022260190Medical Facets NCMDF-02-226-019MDF-02-226-0192015-10-09
M933MDF022260200Medical Facets NCMDF-02-226-020MDF-02-226-0202015-10-09
M933MDF022260210Medical Facets NCMDF-02-226-021MDF-02-226-0212015-10-09
M933MDF022260220Medical Facets NCMDF-02-226-022MDF-02-226-0222015-10-09
M933MDF022260230Medical Facets NCMDF-02-226-023MDF-02-226-0232015-10-09
M933MDF022260240Medical Facets NCMDF-02-226-024MDF-02-226-0242015-10-09
M933MDF022260250Medical Facets NCMDF-02-226-025MDF-02-226-0252015-10-09
M933MDF022260260Medical Facets NCMDF-02-226-026MDF-02-226-0262015-10-09
M933MDF022260270Medical Facets NCMDF-02-226-027MDF-02-226-0272015-10-09
M933MDF022260280Medical Facets NCMDF-02-226-028MDF-02-226-0282015-10-09
M933MDF022260290Medical Facets NCMDF-02-226-029MDF-02-226-0292015-10-09
M933MDF022260300Medical Facets NCMDF-02-226-030MDF-02-226-0302015-10-09

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