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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (4) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (3) Appliance, Fixation, Spinal Interlaminal (KWP) (3) Orthosis, Spinal Pedicle Fixation (MNI) (3) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (3) Orthopedic Manual Surgical Instrument (LXH) (2) Holder, Needle; Orthopedic (HXK) (1)

Premarket Exempt

No Yes

Clear

Hexanium® TLIF - 03663136033211 Catalog Number :

Device Description : Ti TLIF Cage Small H13 mm

Device Class : 2

Duns Number: 390377518

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033228 Catalog Number :

Device Description : Ti TLIF Cage Small H14 mm

Device Class : 2

Duns Number: 390377518

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033235 Catalog Number :

Device Description : Ti TLIF Cage Small H15 mm

Device Class : 2

Duns Number: 390377518

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033242 Catalog Number :

Device Description : Ti TLIF Cage Small H16 mm

Device Class : 2

Duns Number: 390377518

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033259 Catalog Number :

Device Description : Snap-On Cannulated Silicon T-Handle

Device Class : 1

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033266 Catalog Number :

Device Description : Ti TLIF Cage Trial Holder

Device Class : 1

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : HXK

Prescription Use : Yes

Device Count : 1

Hexanium® TLIF - 03663136033273 Catalog Number :

Device Description : Ti TLIF Instruments Tray

Device Class : 1

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033280 Catalog Number :

Device Description : Rod holder

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033297 Catalog Number :

Device Description : Rod gripper

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNI, MNH

Prescription Use : Yes

Device Count : 1

PLUS™ - 03663136033303 Catalog Number :

Device Description : Right sagittal bender

Device Class : 2

Duns Number: 390377518

Premarket Exempt : Yes

Product Code : KWQ, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 1

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