FDA.reportPublic FDA data

Leith Medical 2.7mm Cortical Screw

Primary DI
B953102700300
Brand
Leith Medical 2.7mm Cortical Screw
Company
Leith Medical LLC
Model
1027-0030
Device description
2.7mm Cortical Screw 30mm Long
Published
2023-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K200062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200062000Foot and Ankle SystemLeith Medical, LLC2021-02-22HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B953102700300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable 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., surgical steel).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter2.7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
512-496-6786tim@leithmedical.com

Regulatory Flags#

DUNS number
062982676
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B95301001501L0Leith Medical Lapidus Plating System0100-1501-L2023-10-06
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B953050011320Leith Medical Lateral Fibular Plating System0500-11322023-10-03
B953050020600Leith Medical Lateral Fibular Plating System0500-20602023-10-03
B953050020920Leith Medical Lateral Fibular Plating System0500-20922023-10-03
B953050021320Leith Medical Lateral Fibular Plating System0500-21322023-10-03
B953060010470Leith Medical Medial Malleolar Plating System0600-10472023-10-03
B953060010770Leith Medical Medial Malleolar Plating System0600-10772023-10-03
B953070010870Leith Medical Medial Malleolar Plating System0700-10872023-10-03
B953070011170Leith Medical Medial Malleolar Plating System0700-11172023-10-03
B953070020870Leith Medical Medial Malleolar Plating System0700-20872023-10-03
B953070021170Leith Medical Medial Malleolar Plating System0700-21172023-10-03
B953080010500Leith Medical MTP Plating System0800-10502023-10-03
B953080010560Leith Medical MTP Plating System0800-10562023-10-03
B953080010620Leith Medical MTP Plating System0800-10622023-10-03
B953080010700Leith Medical MTP Plating System0800-10702023-10-03
B953080020500Leith Medical MTP Plating System0800-20502023-10-03
B953080020560Leith Medical MTP Plating System0800-20562023-10-03
B953080020620Leith Medical MTP Plating System0800-20622023-10-03

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