Shoulder Innovations, Inc.

Address:1535 Steele Ave SW,Grand Rapids,MI,49507,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, Hemi-, Humeral, Metallic Uncemented (HSD) (10) Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (KWT) (10) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (10)

Premarket Exempt

Clear

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR200750 Catalog Number : 0S1GR20075

Device Description : Glenoid Reamer Assembly - 20MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR22065 Catalog Number : 0S1GR22065

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR220750 Catalog Number : 0S1GR22075

Device Description : Glenoid Reamer Assembly - 22MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR240650 Catalog Number : 0S1GR24065

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR240750 Catalog Number : 0S1GR24075

Device Description : Glenoid Reamer Assembly - 24MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR270650 Catalog Number : 0S1GR27065

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR270750 Catalog Number : 0S1GR27075

Device Description : Glenoid Reamer Assembly - 27MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR300650 Catalog Number : 0S1GR30065

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR300750 Catalog Number : 0S1GR30075

Device Description : Glenoid Reamer Assembly - 30MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations, LLC - B1130S1GS000020 Catalog Number : 0S1GS00002

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

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