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

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (5) Cement, Bone, Vertebroplasty (NDN) (3) Appliance, Fixation, Spinal Interlaminal (KWP) (2) Tamp (HXG) (2)

Premarket Exempt

Clear

PLIF LITE - 08057432565685 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

PLIF LITE - 08057432565692 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

PLIF LITE - 08057432565708 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

PLIF LITE - 08057432565715 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

PLIF LITE - 08057432565722 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : MAX

Prescription Use : No

Device Count : 1

ACP - 08057432565739 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

ACP - 08057432565746 Catalog Number :

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : KWP

Prescription Use : No

Device Count : 1

SPIDER KOLIBRI - 08057432565784 Catalog Number :

Device Class : 1

Duns Number: 544150399

Premarket Exempt : No

Product Code : HXG, NDN

Prescription Use : No

Device Count : 1

SPIDER KOLIBRI - 08057432565791 Catalog Number :

Device Class : 1

Duns Number: 544150399

Premarket Exempt : No

Product Code : NDN, HXG

Prescription Use : No

Device Count : 1

SINPLUS S - 08057432566149 Catalog Number : 8005

Device Class : 2

Duns Number: 544150399

Premarket Exempt : No

Product Code : NDN

Prescription Use : Yes

Device Count : 1

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