QUANDARY MEDICAL LLC

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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

Appliance, Fixation, Spinal Intervertebral Body (KWQ) (7) Orthopedic Manual Surgical Instrument (LXH) (3)

Premarket Exempt

Yes No

Clear

TranS1 - 00815361020501 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, S1 40 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020518 Catalog Number :

Device Description : AxiaLIF Plus 1-Level, S1 25 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020525 Catalog Number :

Device Description : AxiaLIF Plus 1-Level, S1 30 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020532 Catalog Number :

Device Description : AxiaLIF Plus 1-Level, S1 35 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020549 Catalog Number :

Device Description : AxiaLIF Plus 1-Level, S1 40 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020556 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 20 mm L5, TS 20 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020563 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 22.5 mm L5, TS 22.5 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Vectre - 00815361020570 Catalog Number :

Device Description : Vectre Wire

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Vectre - 00815361020587 Catalog Number :

Device Description : Vectre System Instrumentation

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Vectre - 00815361020594 Catalog Number :

Device Description : XL Vectre Wire

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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