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) (10)

Premarket Exempt

No Yes

Clear

Idys®-LLIF 3DTi - 03700780638444 Catalog Number : 51702160

Device Description : BLADE (LG 160 MM)

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638451 Catalog Number : 51702170

Device Description : BLADE (LG 170 MM)

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638468 Catalog Number : 51702180

Device Description : BLADE (LG 180 MM)

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638475 Catalog Number : 51709000

Device Description : LATERAL RETRACTOR

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638482 Catalog Number : 51720002

Device Description : RETRACTOR SCREWDRIVER

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638499 Catalog Number : 51990007

Device Description : IDYS® LLIF LATERAL RETRACTOR TRAY #1

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638505 Catalog Number : 51990009

Device Description : IDYS®LLIF LATERAL RETRACTOR LID

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638512 Catalog Number : 51707001

Device Description : DILATOR

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638529 Catalog Number : 51707002

Device Description : DILATOR

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

Idys®-LLIF 3DTi - 03700780638536 Catalog Number : 51707003

Device Description : DILATOR

Device Class : 2

Duns Number: 296568400

Premarket Exempt : No

Product Code : OVD

Prescription Use : Yes

Device Count : 1

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