SINTEA PLUSTEK SRL

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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)

Premarket Exempt

Clear

PLS - 08057432565388 Catalog Number :

Device Description : https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548#

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565395 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565401 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565418 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565425 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565432 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565449 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565456 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565463 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

PLS - 08057432565470 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

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