FDA.reportPublic FDA data

Cancellous Bone Screw

Primary DI
B046WF110070
Brand
Cancellous Bone Screw
Company
SIGNAL MEDICAL CORPORATION
Model
45mm
Catalog number
WF-1-1007
Device description
45mm x 6.5mm Cancellous Bone Screw
Published
2019-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961157000WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREWWhiteside Biomechanics, Inc.1996-05-17HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B046WF110070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA 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

Contacts#

Phone, Email table
PhoneEmail
8103647070vfowler@signalmd.com

Regulatory Flags#

DUNS number
169289308
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B046BIO110830PCL RetractorN/ABIO-1-10832023-02-21
B046BIO11081Femoral BeltN/ABIO-1-10812022-06-17
B046BIO11082Tibial BeltN/ABIO-1-10822022-05-12
B046BIO110840Lateral RetractorN/ABIO-1-10842022-05-12
B046BIO110350Gel Pad"46"""BIO-1-10352022-02-10
B046BIO110210Slide BlockBIO-1-1021BIO-1-10212021-10-22
B046BIO110220Boot AssemblyBIO-1-1022BIO-1-10222021-10-22
B046BIO110240End StopBIO-1-1024BIO-1-10242021-10-22
B046BIO11012A0Low Profile Cable1.5mm CableBIO-1-1012-A2021-08-26
B046BIO110120CoCr Low Profile Cable System1.5mm CableBIO110122016-01-12
B046WF110010Cancellous Bone Screw15mmWF-1-10012016-08-05
B046WF110020Cancellous Bone Screw20mmWF-1-10022016-01-07
B046WF110030Cancellous Bone Screw25mmWF-1-10032016-02-12
B046WF110040Cancellous Bone Screw30mmWF-1-10042016-01-07
B046WF110050Cancellous Bone Screw35mmWF-1-10052015-12-16
B046WF110060Cancellous Bone Screws40mmWF-1-10062015-12-16
B046WF110080Cancellous Bone Screw50mmWF-1-10082019-03-22
B046BIO110930Straight Osteotome"1/2"""BIO-1-10932023-04-24
B046BIO110440Knee OsteogatorN/ABIO-1-10442023-03-14
B046WZC26550Femoral Wedge3-4 Distal HalfWZ-C-26552019-01-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
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