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

Tray, Surgical, Instrument (FSM) (3) Orthopedic Manual Surgical Instrument (LXH) (2) System, Facet Screw Spinal Device (MRW) (2) Screwdriver (HXX) (1)

Premarket Exempt

No Yes

Clear

Decima Spine Instrument Kit - 00857360007114 Catalog Number : 6128

Device Description : Cassette Assembly

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007138 Catalog Number : 6139

Device Description : Decima Spine Instrument Kit, Tray Assembly

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007145 Catalog Number : 9061-00

Device Description : Decima Spine Instrument Kit

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

FCD-2 IMPLANT SYSTEM - 00857360007176 Catalog Number : 9062-00

Device Description : FCD-2 Implant System, Stabilizer

Device Class : U

Duns Number: 080963983

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

FCD-2 IMPLANT SYSTEM - 00857360007190 Catalog Number : 9063-00

Device Description : FCD-2 Implant System, ANCHOR

Device Class : U

Duns Number: 080963983

Premarket Exempt : No

Product Code : MRW

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007206 Catalog Number : 6158

Device Description : FCD-2 Removal Cassette Assembly

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007213 Catalog Number : 6134

Device Description : FCD-2 Stabilizer Removal Tool

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

Decima Spine Instrument Kit - 00857360007220 Catalog Number : 9067-00

Device Description : FCD-2 Removal Kit

Device Class : 1

Duns Number: 080963983

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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