FDA.reportPublic FDA data

Leith Medical 2.7mm Cortical Screw

Primary DI
B953102700400
Brand
Leith Medical 2.7mm Cortical Screw
Company
Leith Medical LLC
Model
1027-0040
Device description
2.7mm Cortical Screw 40mm Long
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
B953102700400PrimaryHIBCC0

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
Length40Millimeter
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
B9530100TRIAL0Leith Medical Plating System Instruments0100-Trial2023-10-06
B9530101TRIAL0Leith Medical Plating System Instruments0101-TRIAL2023-10-06
B9530200TRIALL0Leith Medical Plating System Instruments0200-TRIAL-L2023-10-06
B9530200TRIALR0Leith Medical Plating System Instruments0200-TRIAL-R2023-10-06
B9530200TRIALS0Leith Medical Plating System Instruments0200-TRIAL-S2023-10-06
B9530300TRIAL0Leith Medical Plating System Instruments0300-TRIAL2023-10-06
B9530400TRIALL0Leith Medical Plating System Instruments0400-TRIAL-L2023-10-06
B9530400TRIALR0Leith Medical Plating System Instruments0400-TRIAL-R2023-10-06
B9530500TRIALL0Leith Medical Plating System Instruments0500-TRIAL-L2023-10-06
B9530500TRIALR0Leith Medical Plating System Instruments0500-TRIAL-R2023-10-06
B9530600TRIAL0Leith Medical Plating System Instruments0600-TRIAL2023-10-06
B9530700TRIALL0Leith Medical Plating System Instruments0700-TRIAL-L2023-10-06
B9530700TRIALR0Leith Medical Plating System Instruments0700-TRIAL-R2023-10-06
B9530800TRIALL0Leith Medical Plating System Instruments0800-TRIAL-L 2023-10-06
B9530800TRIALR0Leith Medical Plating System Instruments0800-TRIAL-R2023-10-06
B95312770000010Leith Medical Plating System Instruments1277-000-001 2023-10-06
B953900200080Leith Medical Plating System Instruments9002-00082023-10-06
B953102700100Leith Medical 2.7mm Cortical Screw1027-00102023-10-05
B953102700120Leith Medical 2.7mm Cortical Screw1027-00102023-10-05

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