TREACE MEDICAL CONCEPTS, INC.

TREACE MEDICAL CONCEPTS, INC.

Address:100 Palmetto Park Place,PONTE VEDRA,FL,32081,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (4) Orthopedic Manual Surgical Instrument (LXH) (4) Guide, Surgical, Instrument (FZX) (2)

Premarket Exempt

No Yes

Clear

Drill Guide - 00810111220002 Catalog Number :

Device Description : Staple Drill Guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Drill Guide - 00810111220019 Catalog Number :

Device Description : Staple Drill Guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

Seeker-Fulcrum - 00810111220026 Catalog Number :

Device Description : Seeker Fulcrum - Left

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Seeker-Fulcrum - 00810111220033 Catalog Number :

Device Description : Seeker Fulcrum - Right

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Seeker-Fulcrum - 00810111220040 Catalog Number :

Device Description : Seeker Fulcrum - Left

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Seeker-Fulcrum - 00810111220057 Catalog Number :

Device Description : Seeker Fulcrum - Right

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Reamer - 00810111220064 Catalog Number :

Device Description : cup reamer

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

Reamer - 00810111220071 Catalog Number :

Device Description : Cone Reamer

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

Reamer - 00810111220088 Catalog Number :

Device Description : Cup reamer

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

Reamer - 00810111220095 Catalog Number :

Device Description : cone reamer

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : Yes

Device Count : 1

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