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) (4) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (4) Orthosis, Spinal Pedicle Fixation (MNI) (4) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (4)

Premarket Exempt

No Yes

Clear

PLUS™ - 03663136033525 Catalog Number :

Device Description : Crosslink Tray

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033532 Catalog Number :

Device Description : Pedicle Preparation Identification Plate

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033549 Catalog Number :

Device Description : PLUS Identification Plate

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™ - 03663136033556 Catalog Number :

Device Description : ULIS Identification Plate

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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