INGEN ORTHOPEDICS, L.L.C.

Address:2650 US HIGHWAY 130,CRANBURY,NJ,08512,US

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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

Shoulder Prosthesis, Reverse Configuration (PHX) (8) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (2)

Premarket Exempt

Clear

Ingen SEVIIN® Shoulder System - B59910301020 Catalog Number : 103-01-02

Device Description : GLENOID COMPONENT, MEDIUM, PEGGED

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910301030 Catalog Number : 103-01-03

Device Description : GLENOID COMPONENT, LARGE, PEGGED

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : KWS

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910401000 Catalog Number : 104-01-00

Device Description : REVERSE HUMERAL CUP, STANDARD

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910401090 Catalog Number : 104-01-09

Device Description : REVERSE HUMERAL CUP, +9 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536000 Catalog Number : 105-36-00

Device Description : REVERSE PE-INLAY, 36 MM DIA CENTERED, +0 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536030 Catalog Number : 105-36-03

Device Description : REVERSE PE-INLAY, 36 MM DIA CENTERED, +3 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536060 Catalog Number : 105-36-06

Device Description : REVERSE PE-INLAY, 36 MM DIA CENTERED, +6 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536100 Catalog Number : 105-36-10

Device Description : REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +0 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536130 Catalog Number : 105-36-13

Device Description : REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +3 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910536160 Catalog Number : 105-36-16

Device Description : REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +6 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

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