FDA.report

Leith Medical TMT Plating System

Primary DI
B953020002450
Brand
Leith Medical TMT Plating System
Company
Leith Medical LLC
Model
0200-0245
Device description
5° x 45mm Left TMT Plate
Published
2023-09-30
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

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K200062000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K200062000Foot and Ankle SystemLeith Medical, LLC2021-02-22HRS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B953020002450PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Angle5degree
Length45Millimeter

Sterilization Methods

Method

Contacts

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

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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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