Dfine, Inc.

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (6) Cement, Bone, Vertebroplasty (NDN) (4)

Premarket Exempt

Clear

SpineSTAR Ablation Instrument (10 15, Long) - 00850696006004 Catalog Number : STR-1015L

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

SpineSTAR Ablation Instrument (5 10, Long) - 00850696006011 Catalog Number : STR-0510L

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

StabiliT Bone Cement and Saturate Mixing System - 00850696006028 Catalog Number : 4457

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

StabiliT VP Fracture Kit - 00850696006073 Catalog Number : VP-0010A

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

StabiliT First Fracture Kit - 00850696006226 Catalog Number : 2003-1

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

StabiliT First Fracture Kit - 00850696006233 Catalog Number : 3353-01

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

STAR Tumor Ablation Kit (10 15, Short) with PowerCURVE - 00850696006240 Catalog Number : RF-1015S-01

Device Description : ala carte packaging

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

STAR Tumor Ablation Kit (5 10, Long) with PowerCURVE - 00850696006257 Catalog Number : RF-0510L-01

Device Description : ala carte packaging

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

STAR Tumor Ablation Kit (5 10, Short) with PowerCURVE - 00850696006264 Catalog Number : RF-0510S-01

Device Description : ala carte packaging

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

STAR Tumor Ablation Kit (10 15, Long) with PowerCURVE - 00850696006271 Catalog Number : RF-1015L-01

Device Description : ala carte packaging

Device Class : 2

Duns Number: 169957607

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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