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) (10)

Premarket Exempt

No Yes

Clear

TranS1 - 00815361020006 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 40 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020013 Catalog Number :

Device Description : AxiaLIF Guide Pin and Extension Set

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020020 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 45 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020037 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 50 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020044 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 55 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020051 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 60 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020068 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 15.5 mm Non-Distracting Rod, 65 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020075 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 40 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020082 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 45 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020099 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 14 mm Non-Distracting Rod, 50 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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