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

Screwdriver (HXX) (4) Countersink (HWW) (2) Tray, Surgical, Instrument (FSM) (2) Instrument, Compression (HWN) (1) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

Driver - 00853114006679 Catalog Number :

Device Description : AO Driver

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Countersink - 00853114006686 Catalog Number :

Device Description : Countersink with handle

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWW

Prescription Use : Yes

Device Count : 1

Countersink - 00853114006693 Catalog Number :

Device Description : Countersink with handle

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWW

Prescription Use : Yes

Device Count : 1

Compressor & Distractor - 00853114006709 Catalog Number :

Device Description : compressor

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HWN

Prescription Use : Yes

Device Count : 1

Instrument Tray - 00853114006716 Catalog Number :

Device Description : Instrument Tray

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Screwdriver - 00853114006723 Catalog Number :

Device Description : Snap-Off Screwdriver

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

AO Driver Tip - 00853114006730 Catalog Number :

Device Description : AO Driver Cannulated

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Ratchet Handle - 00853114006747 Catalog Number :

Device Description : Cannulated Ratchet Handle

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Instrument Tray - 00853114006754 Catalog Number :

Device Description : Instrument Tray

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Cut Guide - 00853114006761 Catalog Number :

Device Description : cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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