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

Orthopedic Manual Surgical Instrument (LXH) (7) Template (HWT) (3)

Premarket Exempt

Clear

M6-C - 00812388030117 Catalog Number : CRP-016-04

Device Description : Cervical Retainer Pin, 16mm

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030124 Catalog Number : RPD-100-06

Device Description : Pin Driver, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030131 Catalog Number : CRA-100-06

Device Description : Retainer, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030148 Catalog Number : CRN-100-04

Device Description : Cervical Retainer Locking Nut

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030155 Catalog Number : CPD-200-06

Device Description : Paddle Distractor, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030162 Catalog Number : CDS-100-06

Device Description : Distractor Spacer, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030179 Catalog Number : CPD-100-06

Device Description : Intervertebral Distractor, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030186 Catalog Number : CFT-200M-06

Device Description : Footprint Template, M/ML, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030193 Catalog Number : CFT-200L-06

Device Description : Footprint Template, L/LL, G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

M6-C - 00812388030209 Catalog Number : CTH-615-06

Device Description : Trial Head, 6M (6mm H x 15mm W x 12.5mm D), G6

Device Class : 1

Duns Number: 171513125

Premarket Exempt : No

Product Code : HWT

Prescription Use : Yes

Device Count : 1

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