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 - B1130S1GG000020 Catalog Number : 0S1GG00002

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG00020 Catalog Number : 0S1GG00020

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG000200 Catalog Number : 0S1GG00020

Device Description : TSA - Peripheral Drill Guide 20mm

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG000220 Catalog Number : 0S1GG00022

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG000240 Catalog Number : 0S1GG00024

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG000270 Catalog Number : 0S1GG00027

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1GG000300 Catalog Number : 0S1GG00030

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GK00020 Catalog Number : 0S1GK0002

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations, TSA - B1130S1GP000050 Catalog Number : 0S1GP00005

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1GR200650 Catalog Number : 0S1GR20065

Device Description : TSA - REAMER/DRILL 20MM

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWT, KWS, HSD

Prescription Use : Yes

Device Count : 1

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