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

Joint, Temporomandibular, Implant (LZD) (7) Orthopedic Manual Surgical Instrument (LXH) (3)

Premarket Exempt

Clear

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046005000 Catalog Number :

Device Description : Sterilization Case Lid

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046005100 Catalog Number :

Device Description : Sterilization Case Screw Base

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046005200 Catalog Number :

Device Description : Sterilization Case Instrument Base

Device Class : 1

Duns Number: 035877922

Premarket Exempt : No

Product Code : LXH

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120050 Catalog Number :

Device Description : Bone Screw 2.0mm x 5mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120060 Catalog Number :

Device Description : Bone Screw 2.0mm x 6mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120080 Catalog Number :

Device Description : Bone Screw 2.0mm x 8mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120100 Catalog Number :

Device Description : Bone Screw 2.0mm x 10mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120120 Catalog Number :

Device Description : Bone Screw 2.0mm x 12mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120140 Catalog Number :

Device Description : Bone Screw 2.0mm x 14mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

Patient-Fitted TMJ Reconstructive Prosthesis System - B0046120160 Catalog Number :

Device Description : Bone Screw 2.0mm x 16mm

Device Class : 3

Duns Number: 035877922

Premarket Exempt : No

Product Code : LZD

Prescription Use : No

Device Count : 1

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