Spinal Kinetics, Inc.

Address:501 Mercury Dr,SUNNYVALE,CA,94085,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

Template (HWT) (8) Manual Instruments Designed For Total Disc Replacement Device (QLQ) (2)

Premarket Exempt

Clear

M6-C - 00812388031060 Catalog Number : CTH-615-07

Device Description : Trial Head, 6M (6mm H x 15mm W x 12.5mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031077 Catalog Number : CTH-715-07

Device Description : Trial Head, 7M (7mm H x 15mm W x 12.5mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031084 Catalog Number : CTH-615L-07

Device Description : Trial Head, 6ML (6mm H x 15mm W x 15mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031091 Catalog Number : CTH-715L-07

Device Description : Trial Head, 7ML (7mm H x 15mm W x 15mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031107 Catalog Number : CTH-617-07

Device Description : Trial Head, 6L (6mm H x 17mm W x 14mm D), G67

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031114 Catalog Number : CTH-717-07

Device Description : Trial Head, 7L (7mm H x 17mm W x 14mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031121 Catalog Number : CTH-617L-07

Device Description : Trial Head, 6LL (6mm H x 17mm W x 16mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031138 Catalog Number : CTH-717L-07

Device Description : Trial Head, 7LL (7mm H x 17mm W x 16mm D), G7

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031145 Catalog Number : CIC-615-07

Device Description : Fin Cutter, 6M (6mm H x 15mm W x 12.5mm D), G7

Device Class : 2

Duns Number: 171513125

Premarket Exempt : No

Product Code : QLQ

Prescription Use : Yes

Device Count : 1

M6-C - 00812388031152 Catalog Number : CIC-715-07

Device Description : Fin Cutter, 7M (7mm H x 15mm W x 12.5mm D), G7

Device Class : 2

Duns Number: 171513125

Premarket Exempt : No

Product Code : QLQ

Prescription Use : Yes

Device Count : 1

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