FDA.reportPublic FDA data

Leith Medical Lapidus Plating System

Primary DI
B95301000003R0
Brand
Leith Medical Lapidus Plating System
Company
Leith Medical LLC
Model
0100-0003-R
Device description
0° Lapidus Plate Right 3mm Step Down
Published
2023-09-30
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, 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
B95301000003R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Width3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
062982676
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B95301001501L0Leith Medical Lapidus Plating System0100-1501-L2023-10-06
B953030000090Leith Medical Plating System0300-00092023-10-03
B953050010920Leith Medical Lateral Fibular Plating System0500-10922023-10-03
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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