KOROS U.S.A., INC.

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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

No Yes

Clear

Cervical Micro Impactor - 10840199500373 Catalog Number : 7222-60

Device Description : Cervical Micro Impactor

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Bone Graft Driver, Guarded - 10840199500380 Catalog Number : 7222-65

Device Description : Bone Graft Driver, Guarded 10mm

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Bone Graft Driver, Guarded - 10840199500397 Catalog Number : 7222-70

Device Description : Bone Graft Driver, Guarded 12mm

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Impactor, Small - 10840199500403 Catalog Number : 7223-10

Device Description : Impactor, Small 3.5 x 8mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Impactor, Medium - 10840199500410 Catalog Number : 7223-20

Device Description : Impactor, Medium 4.6 x 10mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Impactor, Large - 10840199500427 Catalog Number : 7223-30

Device Description : Impactor, Large 4.8 x 12.5mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Offset Impactor - 10840199500434 Catalog Number : 7223-40

Device Description : Offset Impactor 8 x 15mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Round Impactor - 10840199500441 Catalog Number : 7223-50

Device Description : Round Impactor 4.5mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Round Impactor - 10840199500458 Catalog Number : 7223-60

Device Description : Round Impactor 12.5mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Bone Impactor - 10840199500465 Catalog Number : 7224-10

Device Description : Bone Impactor 5 x 11.5mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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