CLARIANCE

Address:18, rue Robespierre,BEAURAINS Hauts-de-France,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

Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD) (7) Orthopedic Manual Surgical Instrument (LXH) (2) Orthosis, Spinal Pedicle Fixation (MNI) (1) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (1) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

No Yes

Clear

Idys®-ALIF ZP 3DTi - 03700780638727 Catalog Number : 99781205

Device Description : TORQUE-LIMITED RATCHETING T-HANDLE (5.5N.M ± 10%)

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-ALIF ZP 3DTi - 03700780638826 Catalog Number : 45700001

Device Description : STRAIGHT PUNCH

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Erisma®-LP - 03700780638833 Catalog Number : 98715000

Device Description : ROD HOLDER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : MNI, NKB, MNH

Prescription Use : Yes

Device Count : 1

Idys®-ALIF ZP 3DTi - 03700780638840 Catalog Number : 99781206

Device Description : TORQUE-LIMITED RATCHETING CYLINDRICAL HANDLE (5.5N.M ± 10%)

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638857 Catalog Number : 51912001

Device Description : BODY OF IMPLANT REMOVER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638864 Catalog Number : 51911002

Device Description : ROD OF IMPLANT REMOVER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

IDYS©-C ZP 3DTI - 03700780639090 Catalog Number :

Device Description : medium AO cylindrical handle

Device Class : 1

Duns Number: 296568400

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

IDYS-C ZP 3DTi - 03700780639106 Catalog Number :

Device Description : Screwdriver T15

Device Class : 1

Duns Number: 296568400

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780639144 Catalog Number : 45916001

Device Description : ROD OF CAGE HOLDER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780639151 Catalog Number : 51911009

Device Description : ROD OF IMPLANT REMOVER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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