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 - 00193082000218 Catalog Number : ACH1-246

Device Description : ALLTUM Anterior Cervical Plate - 2 Levels, L46mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000225 Catalog Number : ACH1-345

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L45mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000232 Catalog Number : ACH1-348

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L48mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000249 Catalog Number : ACH1-351

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L51mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000256 Catalog Number : ACH1-354

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L54mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000263 Catalog Number : ACH1-357

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L57mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000270 Catalog Number : ACH1-360

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L60mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000287 Catalog Number : ACH1-363

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L63mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000294 Catalog Number : ACH1-366

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L66mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

ALLTUM - 00193082000300 Catalog Number : ACH1-369

Device Description : ALLTUM Anterior Cervical Plate - 3 Levels, L69mm

Device Class : 2

Duns Number: 783908713

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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