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 - 00815361020105 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 14 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 - 00815361020112 Catalog Number :

Device Description : AxiaLIF Plus 1-Level 14 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 - 00815361020129 Catalog Number :

Device Description : AXiaLIF Plus 1-Level 14 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 - 00815361020136 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 70 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020143 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 75 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020150 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 80 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020167 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 85 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020174 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 15.5 mm Non-Distracting Rod, 90 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020181 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 70 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020198 Catalog Number :

Device Description : AxiaLIF Plus 2-Level 14 mm Non-Distracting Rod, 75 mm Length

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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