FDA.report

Leith Medical Plating System Instruments

Primary DI
B9530101TRIAL0
Brand
Leith Medical Plating System Instruments
Company
Leith Medical LLC
Model
0101-TRIAL
Device description
Lapidus Plate Trial Right
Published
2023-10-06
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
false

Related Records

Contact Domains

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K200062000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B9530101TRIAL0PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical instrument/implant depth limiterA device designed to limit the depth of insertion of a surgical instrument (e.g., a drill bit or a reamer), a trial implant, or an implant. It may be used as a stand-alone device or it may be attached to another device to control insertion depth, typically to prevent insertion below the surgical field of interest thereby avoiding damage to tissue behind or below target structures. It is typically made of high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.

Device Sizes

TypeValueUnit
Length1.75Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
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 DIBrandModelCatalogPublished
B95301001501L0Leith Medical Lapidus Plating System0100-1501-L2023-10-06
B9530100TRIAL0Leith Medical Plating System Instruments0100-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
B953102700140Leith Medical 2.7mm Cortical Screw1027-00142023-10-05

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