Nexus Cmf, L.L.C.

Address:2825 E. Cottonwood Parkway,Salt Lake City,UT,84121,US

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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) (10) Glenoid Fossa Prosthesis (MPI) (8)

Premarket Exempt

Clear

3.0 × 10.0 mm Auxiliary Screw - M9575001030 Catalog Number :

Device Description : 3.0 × 10.0 mm Auxiliary Screw

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

3.0 × 12.0 mm Auxiliary Screw - M9575001040 Catalog Number :

Device Description : 3.0 × 12.0 mm Auxiliary Screw

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Fossa-Eminence Prosthesis (LEFT SIDE) - M9575001050 Catalog Number :

Device Description : Patient-Specific TMJ Fossa-Eminence Prosthesis (LEFT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Fossa-Eminence Prosthesis (RIGHT SIDE) - M9575001060 Catalog Number :

Device Description : Patient-Specific TMJ Fossa-Eminence Prosthesis (RIGHT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : LZD, MPI

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE) - M9575001070 Catalog Number :

Device Description : Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : LZD, MPI

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Fossa-Eminence Trial Sizer (RIGHT SIDE) - M9575001080 Catalog Number :

Device Description : Patient-Specific TMJ Fossa-Eminence Trial Sizer (RIGHT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE) - M9575001090 Catalog Number :

Device Description : Patient-Specific TMJ Condylar Prosthesis (LEFT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE) - M9575001100 Catalog Number :

Device Description : Patient-Specific TMJ Condylar Prosthesis (RIGHT SIDE)

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : LZD

Prescription Use : Yes

Device Count : 1

2.0x6.0mm [1] & 2.0x8.0mm [4] Screws - M9575001110 Catalog Number :

Device Description : 2.0x6.0mm [1] & 2.0x8.0mm [4] Screws

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

2.7x8.0mm [2] & 2.7x10.0mm [5] Screws - M9575001120 Catalog Number :

Device Description : 2.7x8.0mm [2] & 2.7x10.0mm [5] Screws

Device Class : 3

Duns Number: 965540227

Premarket Exempt : No

Product Code : MPI, LZD

Prescription Use : Yes

Device Count : 1

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