FDA.reportPublic FDA data

StabilizOrtho

Primary DI
B650SCS370450
Brand
StabilizOrtho
Company
Stabiliz Orthopaedics, Inc.
Model
SCS37045
Device description
SimpliFix Cross Screw 3.7mm x 45mm
Published
2024-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K230053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230053000SimpliFix Hip SystemStabiliz Orthopaedics, Inc.2023-04-19HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B650SCS370450PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832740091
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B650SCS370500StabilizOrthoSCS370502024-10-31
B650SCS370550StabilizOrthoSCS370552024-10-31
B650SCS370600StabilizOrthoSCS370602024-10-31
B650SCS370650StabilizOrthoSCS370652024-10-31
B650SCS370700StabilizOrthoSCS370702024-10-31
B650SCS370750StabilizOrthoSCS370752024-10-31
B650SCS370800StabilizOrthoSCS370802024-10-31
B650SCS370850StabilizOrthoSCS370852024-10-31
B650SCS370900StabilizOrthoSCS370902024-10-31
B650SFX830700StabilizOrthoSFX830702024-10-31
B650SFX830750StabilizOrthoSFX830752024-10-31
B650SFX830800StabilizOrthoSFX830802024-10-31
B650SFX830850StabilizOrthoSFX830852024-10-31
B650SFX830900StabilizOrthoSFX830902024-10-31
B650SFX830950StabilizOrthoSFX830952024-10-31
B650SFX831000StabilizOrthoSFX831002024-10-31
B650SFX831050StabilizOrthoSFX831052024-10-31
B650SFX831100StabilizOrthoSFX831102024-10-31
B650SFX831150StabilizOrthoSFX831152024-10-31
B650SFX831200StabilizOrthoSFX831202024-10-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
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08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
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