SPINEWAY

Address:7 Allee Moulin Berger,Ecully Auvergne-Rhone-Alpes,FR

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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) Orthosis, Spinal Pedicle Fixation (MNI) (10) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (10) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (10) Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (OSH) (10)

Premarket Exempt

Clear

Mont Blanc Spinal Systems - 03663422000057 Catalog Number : MB1LLH

Device Description : LAMINAR LUMBAR HOOK

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : NKB, MNI, MNH, KWP, OSH

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000064 Catalog Number : MB1LLO

Device Description : LUMBAR LAMINAR HOOK LEFT OFFSET BODY

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : KWP, OSH, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000071 Catalog Number : MB1LMB

Device Description : LAMINAR MEDIUM HOOK THIN BLADE

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : NKB, MNI, MNH, OSH, KWP

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000088 Catalog Number : MB1LMH

Device Description : LAMINAR LUMBAR MEDIUM HOOK

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : KWP, OSH, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000095 Catalog Number : MB1LRO

Device Description : LUMBAR LAMINAR HOOK RIGHT OFFSET BODY

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : NKB, MNI, MNH, OSH, KWP

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000101 Catalog Number : MB1LS

Device Description : LOCKING SCREW

Device Class :

Duns Number: 281075270

Premarket Exempt : No

Product Code : NKB, OSH, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 2

Mont Blanc Spinal Systems - 03663422000118 Catalog Number : MB1LTH

Device Description : LAMINAR THORACIC HOOK

Device Class : 2

Duns Number: 281075270

Premarket Exempt : No

Product Code : OSH, KWP, MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

Mont Blanc Spinal Systems - 03663422000125 Catalog Number : MB1MS425

Device Description : PEDICLE MONOBLOC SCREW Ø:4 L25mm

Device Class :

Duns Number: 281075270

Premarket Exempt : No

Product Code : MNI, MNH, KWP, OSH, NKB

Prescription Use : Yes

Device Count : 2

Mont Blanc Spinal Systems - 03663422000132 Catalog Number : MB1MS430

Device Description : PEDICLE MONOBLOC SCREW Ø:4 L30mm

Device Class :

Duns Number: 281075270

Premarket Exempt : No

Product Code : NKB, OSH, KWP, MNH, MNI

Prescription Use : Yes

Device Count : 2

Mont Blanc Spinal Systems - 03663422000149 Catalog Number : MB1MS435

Device Description : PEDICLE MONOBLOC SCREW Ø:4 L35mm

Device Class :

Duns Number: 281075270

Premarket Exempt : No

Product Code : MNI, MNH, KWP, OSH, NKB

Prescription Use : Yes

Device Count : 2

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