SYNTHES (U.S.A.) LP

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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

PROSTHESIS, INTERVERTEBRAL DISC (MJO) (10)

Premarket Exempt

No Yes

Clear

ProDisc - 10705034700014 Catalog Number : PDLLIP00S

Device Description : INFERIOR END PLATE LARGE-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700045 Catalog Number : PDLLPT10S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-10MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700052 Catalog Number : PDLLPT12S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-12MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700069 Catalog Number : PDLLPT14S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700083 Catalog Number : PDLLSP06S

Device Description : SUPERIOR END PLATE LARGE 6°-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700090 Catalog Number : PDLLSP11S

Device Description : SUPERIOR END PLATE LARGE 11°-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700106 Catalog Number : PDLMIP00S

Device Description : INFERIOR END PLATE MEDIUM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700137 Catalog Number : PDLMPT10S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-10MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700144 Catalog Number : PDLMPT12S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-12MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

ProDisc - 10705034700151 Catalog Number : PDLMPT14S

Device Description : POLYETHYLENE INLAY W/TANTALUM MARKER/MEDIUM-14MM-STERILE

Device Class : 3

Duns Number: 832637081

Premarket Exempt : No

Product Code : MJO

Prescription Use : Yes

Device Count : 1

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