DECIMA SPINE, INC.

DECIMA SPINE, INC.

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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) (4) Screwdriver (HXX) (3) Countersink (HWW) (1) Passer, Wire, Orthopedic (HXI) (1) Tap, Bone (HWX) (1)

Premarket Exempt

No Yes

Clear

Decima Spine Instrument Kit - 00857360007008 Catalog Number : 6072-00

Device Description : Kichner Wire

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HXI

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007015 Catalog Number : 6079

Device Description : Quick Release Handle

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007039 Catalog Number : 6086-01

Device Description : 11mm Deciport

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007046 Catalog Number : 6093

Device Description : Countersink

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HWW

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007053 Catalog Number : 6094

Device Description : Driver

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007060 Catalog Number : 6095

Device Description : INSERTION TOOL

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007077 Catalog Number : 6096

Device Description : REMOVAL DRIVER

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007084 Catalog Number : 6118

Device Description : Pre-Drill

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007091 Catalog Number : 6119

Device Description : Tap

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007107 Catalog Number : 6120

Device Description : Slap Hammer

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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