SPINEVISION

Address:185 Alewife Brook Pkwy Ste 402,Cambridge,MA,02138,US

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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 Interlaminal (KWP) (10) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (10) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10)

Premarket Exempt

No Yes

Clear

U.L.I.S™ - 03663136033426 Catalog Number :

Device Description : Tray 5 ULIS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

U.L.I.S™ - 03663136033433 Catalog Number :

Device Description : Screws Rack

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033440 Catalog Number :

Device Description : Tray 1 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033457 Catalog Number :

Device Description : Tray 2 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033464 Catalog Number :

Device Description : Tray 3 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033471 Catalog Number :

Device Description : Tray 4 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033488 Catalog Number :

Device Description : Tray 5 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNI, MNH

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033495 Catalog Number :

Device Description : Tray 6 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNI, MNH

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033501 Catalog Number :

Device Description : Tray 7 PLUS

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWP, KWQ, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033518 Catalog Number :

Device Description : Cannulated Ratcheting Cylindrical Handle

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

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