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

Orthopedic Manual Surgical Instrument (LXH) (8) Chisel, Surgical, Manual (FZO) (1) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

Cut Guide - 00810111220422 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220439 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220446 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220453 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220460 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220477 Catalog Number :

Device Description : low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Cut Guide - 00810111220484 Catalog Number :

Device Description : Low pro cut guide

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Instrument Tray - 00810111220491 Catalog Number :

Device Description : Instrument Tray

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Chisel - 00810111220514 Catalog Number :

Device Description : Corner Chisel

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : FZO

Prescription Use : Yes

Device Count : 1

cut guide, fulcrum, seeker - 00810111220521 Catalog Number :

Device Description : Mini 3 in 1 Right

Device Class : 1

Duns Number: 054808082

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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