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

90 deg Suction Retractor - 10840199500137 Catalog Number :

Device Description : 90 deg Suction Retractor

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

90 deg T Impactor - 10840199500144 Catalog Number :

Device Description : 90 deg T Impactor 6x12mm

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

90 deg L Offset Impactor - 10840199500151 Catalog Number :

Device Description : 90 deg L Offset Impactor 6x12mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Dissector Perforator - 10840199500168 Catalog Number :

Device Description : Dissector Perforator with 13mm tip

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Bayonet Suction Retractor - 10840199500182 Catalog Number :

Device Description : Bayonet Suction Retractor 7mm tip 12 cm working length

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

90 degree Suction - 10840199500199 Catalog Number :

Device Description : 90 degree Suction 9mm tipx12cm working length

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

90 degree Suction - 10840199500205 Catalog Number : 7220-20

Device Description : 90 degree Suction 7mm tip x 12cm working length

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

90 Degree Suction - 10840199500212 Catalog Number :

Device Description : 90 Degree Suction 9mm tip x 15cm working length

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Suction Retractor Cleaning Wire - 10840199500229 Catalog Number : 7220-35

Device Description : Suction Retractor Cleaning Wire

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Nerve Root Retractor - 10840199500236 Catalog Number : 7233-54

Device Description : Nerve Root Retractor

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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