Nanoplasty System

GUDID 00810111222525

Bicortical Screw Pack

Treace Medical Concepts, Inc.

Orthopaedic bone screw (non-sliding)
Primary Device ID00810111222525
NIH Device Record Key24119308-6162-4655-bd04-b677227227ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameNanoplasty System
Version Model NumberSD29
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111222525 [Primary]

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-17
Device Publish Date2024-05-09

On-Brand Devices [Nanoplasty System]

00810111222525Bicortical Screw Pack
00810111222471Loading Block
00810111222464Bunion Correction Implants
00810111222457Inserter
00810111222426Drill Guide
00810111222402Drill Guide
00810111222532Rotational Guide
00810111222907Rotation Guide Base
00810111222884Inserter
00810111222914Rotation Guide Extension
00810111222891Drill Guide
008101112224191st Met Inserter Draw Bar

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