FDA.reportPublic FDA data

Leith Medical MTP Plating System

Primary DI
B953080520700
Brand
Leith Medical MTP Plating System
Company
Leith Medical LLC
Model
0805-2070
Device description
70mm 5° MTP Plate Right
Published
2023-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B953080520700PrimaryHIBCC0

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
Angle5degree
Length70Millimeter

Sterilization Methods#

Method table
Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
05055662971552Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
05055662971569Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHRS2026-03-04
08809986480521CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-03-04
00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535091Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23