FDA.reportPublic FDA data

Medical Facets NC

Primary DI
M933MDF219989
Brand
Medical Facets NC
Company
MEDICAL FACETS NC LLC
Model
MDF-219-989
Catalog number
MDF-219-989
Device description
Washer, OD 13mm, ID 6.8mm
Published
2016-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
M933MDF219989PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Implantable bone washerAn implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
061276724
Device count
1
Premarket exempt
true
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
M933MDF022260100Medical Facets NCMDF02226010MDF022260102015-10-12
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

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00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
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00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
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