INGEN ORTHOPEDICS, L.L.C.

Address:2650 US HIGHWAY 130,CRANBURY,NJ,08512,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, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (10)

Premarket Exempt

Clear

Ingen SEVIIN® Shoulder System - B59910001000 Catalog Number : 100-01-00

Device Description : HUMERAL STEM, SIZE 1 STANDARD, 6 MM DIA X 100 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910002010 Catalog Number : 100-02-01

Device Description : HUMERAL STEM, SIZE 2 STANDARD, 8 MM DIA X 110 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910003010 Catalog Number : 100-03-01

Device Description : HUMERAL STEM, SIZE 3 STANDARD, 10 MM DIA X 120 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910004010 Catalog Number : 100-04-01

Device Description : HUMERAL STEM, SIZE 4 STANDARD, 12 MM DIA X 120 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910005010 Catalog Number : 100-05-01

Device Description : HUMERAL STEM, SIZE 5 STANDARD, 14 MM DIA X 125 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910140150 Catalog Number : 101-40-15

Device Description : HUMERAL HEAD, STANDARD, 40 MM DIA X 15 MM HEIGHT

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910140180 Catalog Number : 101-40-18

Device Description : HUMERAL HEAD, STANDARD, 40 MM DIA X 18 MM HEIGHT

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910140210 Catalog Number : 101-40-21

Device Description : HUMERAL HEAD, STANDARD, 40 MM DIA X 21 MM HEIGHT

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910144150 Catalog Number : 101-44-15

Device Description : HUMERAL HEAD, STANDARD, 44 MM DIA X 15 MM HEIGHT

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910144180 Catalog Number : 101-44-18

Device Description : HUMERAL HEAD, STANDARD, 44 MM DIA X 18 MM HEIGHT

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

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