H.P.I.

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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

Spinal Vertebral Body Replacement Device (MQP) (10)

Premarket Exempt

Clear

SUPSTANCE Small - 00370049613881 Catalog Number : 100114842

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613300 Catalog Number : 100112518

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613324 Catalog Number : 100112520

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613348 Catalog Number : 100112522

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613362 Catalog Number : 100112524

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613386 Catalog Number : 100112526

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613409 Catalog Number : 100112528

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613423 Catalog Number : 100112530

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613447 Catalog Number : 100112832

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

SUPSTANCE Small - 03700449613461 Catalog Number : 100112834

Device Description : The SUPSTANCE Small VBR system is a PEEK Optima vertebral body replacement (VBR)

Device Class : 2

Duns Number: 268469389

Premarket Exempt : No

Product Code : MQP

Prescription Use : No

Device Count : 1

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