SPINECRAFT, LLC

Address:777 Oakmont Ln Suite 200,Westmont,IL,60559,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

Appliance, fixation, spinal intervertebral body (KWQ) (10)

Premarket Exempt

No Yes

Clear

ALLTUM - 00193082000317 Catalog Number : ACH1-460

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L60mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000324 Catalog Number : ACH1-464

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L64mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000331 Catalog Number : ACH1-468

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L68mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000348 Catalog Number : ACH1-472

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L72mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000355 Catalog Number : ACH1-476

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L76mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000362 Catalog Number : ACH1-480

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L80mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000379 Catalog Number : ACH1-484

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L84mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000386 Catalog Number : ACH1-488

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L88mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000393 Catalog Number : ACH1-492

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L92mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000409 Catalog Number : ACH1-496

Device Description : ALLTUM Anterior Cervical Plate - 4 Levels, L96mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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