Kapp Surgical Instrument Co.

Address:4919 WARRENSVILLE CENTER RD.,WARRENSVILLE HEIGHTS,OH,44128,US

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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

Prosthesis, Elbow, Hemi-, Radial, Polymer (KWI) (5) Prosthesis, Wrist, Hemi-, Ulnar (KXE) (5)

Premarket Exempt

No Yes

Clear

Seitz Solution Unlar Head - B033KCS72 Catalog Number : KCS-72

Device Description : 7.5x2mm Spacer

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KXE

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCSI519 Catalog Number : KCSI-519

Device Description : 5x19mm Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCSI621 Catalog Number : KCSI-621

Device Description : 6x21mm Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCSI722 Catalog Number : KCSI-722

Device Description : 7x22mm Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCSI824 Catalog Number : KCSI-824

Device Description : 8x24mm Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Radial Head - B033KCSI925 Catalog Number : KCSI-925

Device Description : 9x25.5mm Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KWI

Prescription Use : Yes

Device Count : 1

Seitz Solution Unlar Head - B033KCUC4854 Catalog Number : KCUC-4854

Device Description : 48x5x4mm Collared Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KXE

Prescription Use : Yes

Device Count : 1

Seitz Solution Unlar Head - B033KCUC4865 Catalog Number : KCUC-4865

Device Description : 48x6.5x5.5.5mm Collared Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KXE

Prescription Use : Yes

Device Count : 1

Seitz Solution Unlar Head - B033KCUC4876 Catalog Number : KCUC-4876

Device Description : 48x7.5x6.5mm Collard Stem

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KXE

Prescription Use : Yes

Device Count : 1

Seitz Solution Unlar Head - B033KCUH1314 Catalog Number : KCUH-1314

Device Description : 13.5x14mm Ulnar Head

Device Class : 2

Duns Number: 004171112

Premarket Exempt : No

Product Code : KXE

Prescription Use : Yes

Device Count : 1

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