FDA.reportPublic FDA data

CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD

Primary DI
00850072364131
Brand
CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
Company
ORTHO OUTCOMES, LLC
Model
104-0207-08
Device description
CURVED WASHER, Ti6Al4V, 7.0 SIZE, 16mm OD
Published
2026-02-28
Public version status
New
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
00850072364131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850072364131008500723641318500723641310850072364131

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone boltA short, implantable rod or shaft designed to be inserted through a long bone (excludes spinal bone) to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
133439875
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850072364025NUT SLEEVE OBTURATOR, 7.0 SIZE104-01382026-05-11
00850072364230DEPTH GAGE, REUSABLE, 7.0mm104-0270-052026-05-11
00850072364292DEPTH GAGE STOP, 7.0 SIZE104-0325-052026-05-11
00850072364315RESCUE DRIVER, 5.0mm HEX, JACOBS-HALL/TRINKLE, CANNULATED104-0340-042026-05-11
00850072364032BOLT, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX104-0156-012026-02-28
00850072364049BOLT, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX104-0156-022026-02-28
00850072364056BOLT, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX104-0156-032026-02-28
00850072364063BOLT, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX104-0156-042026-02-28
00850072364070BOLT, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX104-0156-052026-02-28
00850072364087NUT SLEEVE, Ti6Al4V, 7.0mm x 80-100mm, 5mm HEX104-0157-012026-02-28
00850072364094NUT SLEEVE, Ti6Al4V, 7.0mm x 100-120mm, 5mm HEX104-0157-022026-02-28
00850072364100NUT SLEEVE, Ti6Al4V, 7.0mm x 120-140mm, 5mm HEX104-0157-032026-02-28
00850072364117NUT SLEEVE, Ti6Al4V, 7.0mm x 140-160mm, 5mm HEX104-0157-042026-02-28
00850072364124NUT SLEEVE, Ti6Al4V, 7.0mm x 160-180mm, 5mm HEX104-0157-052026-02-28
00850072364148CURVED WASHER, Ti6Al4V, 7.0 SIZE, 19mm OD104-0207-092026-02-28
00850072364155GUIDEWIRE, 3.2 x 510mm, DRILL POINT104-0217-032026-02-28
00850072364162GUIDEWIRE, 3.2 x 660mm, DRILL POINT104-0217-062026-02-28
00850072364179DRILL, 7.0mm DIA, CANNULATED104-0218-052026-02-28
00850072364193GUIDEWIRE, 2.4 x 510mm, ROUND ENDS104-0262-052026-02-28
00850072364209GUIDEWIRE, 2.4 x 660mm, ROUND ENDS104-0262-082026-02-28

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