Lapiplasty SpeedPlate

GUDID 00810111222594

Inserter Cap

Treace Medical Concepts, Inc.

Orthopaedic bone staple, non-adjustable
Primary Device ID00810111222594
NIH Device Record Key57db3838-4b5f-456b-9527-b7f7455d8c1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapiplasty SpeedPlate
Version Model Number02-00178
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111222594 [Primary]

FDA Product Code

JDRStaple, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


[00810111222594]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-11
Device Publish Date2024-06-03

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00810111221672Rapid Compression Implants
00810111222105Threaded Rods
00810111222099Threaded Rods
00810111221788Rapid Compression Implants
00810111221771Rapid Compression Implants
00810111221764Rapid Compression Implants
00810111221757Inserter Cap
00810111221740Inserter Cap
00810111222303Instrument Tray
00810111222396Rapid Compression Implants
00810111222600Inserter Rod
00810111222594Inserter Cap
00810111222587Rapid Compression Implants
00810111220293Inserter Cap
00810111223607Micro-Quad™ Inserter Cap 15.5MM

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