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

Shoulder Prosthesis, Reverse Configuration (PHX) (10)

Premarket Exempt

Clear

Ingen SEVIIN® Shoulder System - B59910640000 Catalog Number : 106-40-00

Device Description : REVERSE GLENOSPHERE, 40MM DIA, STANDARD

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910640040 Catalog Number : 106-40-04

Device Description : REVERSE GLENOSPHERE, 40 MM DIA, +4 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910640100 Catalog Number : 106-40-10

Device Description : REVERSE GLENOSPHERE, 40 MM DIA, ECCENTRIC

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910701250 Catalog Number : 107-01-25

Device Description : REVERSE METAGLENE PLATE, 25 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910701290 Catalog Number : 107-01-29

Device Description : REVERSE METAGLENE PLATE, 29 MM

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910702150 Catalog Number : 107-02-15

Device Description : REVERSE BONE SCREW, 4.5 MM DIA X 15 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910702200 Catalog Number : 107-02-20

Device Description : REVERSE BONE SCREW, 4.5 MM DIA X 20 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910702250 Catalog Number : 107-02-25

Device Description : REVERSE BONE SCREW, 4.5 MM DIA X 25 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910702300 Catalog Number : 107-02-30

Device Description : REVERSE BONE SCREW, 4.5 MM DIA X 30 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

Ingen SEVIIN® Shoulder System - B59910702350 Catalog Number : 107-02-35

Device Description : REVERSE BONE SCREW, 4.5 MM DIA X 35 MM LONG

Device Class : 2

Duns Number: 187232066

Premarket Exempt : No

Product Code : PHX

Prescription Use : Yes

Device Count : 1

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