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) (10) Shoulder Prosthesis, Reverse Configuration (PHX) (10)

Premarket Exempt

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Shoulder Innovations Inset Reverse Total Shoulder - B1132R2HS000000 Catalog Number : 2R2HS00000

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Tray Separator

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 - B1132R2SL003330 Catalog Number : 2R2SL00333

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +3mm, 33mm

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 - B1132R2SL003360 Catalog Number : 2R2SL00336

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +3mm, 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 - B1132R2SL003390 Catalog Number : 2R2SL00339

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +3mm, 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 - B1132R2SL003420 Catalog Number : 2R2SL00342

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +3mm, 42mm

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 - B1132R2SL006330 Catalog Number : 2R2SL00633

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +6mm, 33mm

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 - B1132R2SL006360 Catalog Number : 2R2SL00636

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +6mm, 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 - B1132R2SL006390 Catalog Number : 2R2SL00639

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +6mm, 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 - B1132R2SL006420 Catalog Number : 2R2SL00642

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offs Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Offset +6mm, 42mm

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 - B1132R2SS000330 Catalog Number : 2R2SS00033

Device Description : Shoulder Innovations Inset Reverse Total Shoulder - RSA Glenosphere Trial - Standard 33mm

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : MBF, PHX

Prescription Use : Yes

Device Count : 1

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