TMJ Solutions, Inc.

TMJ Solutions, Inc.

Address:6059 King Drive,San Buenaventura,CA,93003,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) (10)

Premarket Exempt

No

Clear

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046000100 Catalog Number :

Device Description : TMJ Driver Handle and Blade (Loaner)

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046000200 Catalog Number :

Device Description : TMJ Fixation Instrument Set (Loaner)

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046001000 Catalog Number :

Device Description : Quick-Connect Instrument Handle

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046001100 Catalog Number :

Device Description : Driver Blade

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046001200 Catalog Number :

Device Description : Implant Stabilizer

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046001300 Catalog Number :

Device Description : Mandibular Forceps

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046002000 Catalog Number :

Device Description : Fossa Seating Tool

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046003000 Catalog Number :

Device Description : Drill Guide

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046004200 Catalog Number :

Device Description : Pilot Drill 2.0mm

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046004230 Catalog Number :

Device Description : Pilot Drill 2.3mm

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

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