Corner Chisel

GUDID 00810111224468

Corner Chisel

Treace Medical Concepts, Inc.

Orthopaedic chisel
Primary Device ID00810111224468
NIH Device Record Key7ef1b08a-24f9-4623-b2fd-aa9030f8d74c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorner Chisel
Version Model Number02-00327
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS100810111224468 [Primary]

FDA Product Code

FZOChisel, Surgical, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


[00810111224468]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-02
Device Publish Date2025-03-25

Devices Manufactured by Treace Medical Concepts, Inc.

00810111225489 - Instrument Tray2026-03-31 Forefoot Instrument Tray
00810111226745 - Instrument Tray2026-03-31 VPCS Hindfoot Tray
00810111227148 - K-Wire2026-03-31 K-Wire
00810111225649 - Depth Gage2026-03-27 K-Wire Depth Gauge
00810111225601 - Reamer2026-03-10 Barrel Reamer
00810111225618 - Reamer2026-03-10 Barrel Reamer
00810111225625 - Reamer2026-03-10 Barrel Reamer
00810111226691 - Positioner / Compressor2026-03-02 LIGHTNING BLOCK - PROXIMAL LEFT

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.