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

Yes No

Clear

TranS1 - 00815361020402 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 55 mm 10 X 12, 55 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020419 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 10, 60 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020426 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 11, 60 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020433 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 60 mm 10 X 12, 60 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020440 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 10, 65 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020457 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 11, 65 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020464 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 65 mm 10 X 12, 65 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020471 Catalog Number :

Device Description : AxiaLIF Plus 2-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 - 00815361020488 Catalog Number :

Device Description : AxiaLIF Plus 2-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 - 00815361020495 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, S1 35 mm Distraction Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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