TMC PSI Cut Guide System

GUDID 00810111222310

Fixation Kit

Treace Medical Concepts, Inc.

Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use Orthopaedic intraoperative positioning pin, single-use

Primary Device ID	00810111222310
NIH Device Record Key	f54108ea-388d-4813-89e9-8ec73e2d270f
Commercial Distribution Status	In Commercial Distribution
Brand Name	TMC PSI Cut Guide System
Version Model Number	NK14
Company DUNS	054808082
Company Name	Treace Medical Concepts, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111222310 [Primary]

FDA Product Code

HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment