FDA.reportPublic FDA data

Leith Medical Plating System Instruments

Primary DI
B95312770000010
Brand
Leith Medical Plating System Instruments
Company
Leith Medical LLC
Model
1277-000-001
Device description
INSTRUMENT FOOT & ANKLE TRAY - 6-PIECE SYSTEM PRODUCTION ORDER
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
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
B95312770000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606637Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606644Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606651Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606668Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606675Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606682Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606699Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606705Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606712Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-07-30
07899258606729Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30
07899258606736Versalock Proximal Tibial Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-07-30