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) (5) Orthopedic Manual Surgical Instrument (LXH) (5)

Premarket Exempt

Yes No

Clear

TranS1 - 00815361020303 Catalog Number :

Device Description : AxiaLIF Plus 26" Guide Wire

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020310 Catalog Number :

Device Description : AxiaLIF Plus Endplate Preparation Rasps

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020327 Catalog Number :

Device Description : AxiaLIF Plus Bowel Retractor Kit

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020334 Catalog Number :

Device Description : AxiaLIF Plus Conformable Tip Tubular Retractor

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020341 Catalog Number :

Device Description : AxiaLIF Plus Single Use Instrument Kit

Device Class : 1

Duns Number: 079938581

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020358 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 10, 50 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020365 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 11, 50 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020372 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 50 mm 10 X 12, 50 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020389 Catalog Number :

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

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

TranS1 - 00815361020396 Catalog Number :

Device Description : AxiaLIF Plus 2-Level, L4-L5 55 mm 10 X 11, 55 mm Fixation Rod

Device Class : 2

Duns Number: 079938581

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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