Shoulder Innovations, Inc.

Address:1535 Steele Ave SW,Grand Rapids,MI,49507,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

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented (MBF) (3) Shoulder Prosthesis, Reverse Configuration (PHX) (3)

Premarket Exempt

Clear

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2SS000360 Catalog Number : 2R2SS00036

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Standard 36mm

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : MBF, PHX

Prescription Use : Yes

Device Count : 1

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2SS000390 Catalog Number : 2R2SS00039

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Standard 39mm

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : MBF, PHX

Prescription Use : Yes

Device Count : 1

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2SS000420 Catalog Number : 2R2SS00042

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Standard 42mm

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : MBF, PHX

Prescription Use : Yes

Device Count : 1

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