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 - B1130S0SS061300 Catalog Number : 0S0SS06130

Device Description : Shoulder Innovations - TSA. Humeral Stem. 6mm x 130 mm. Cobalt Chrome.

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : HSD, KWS, KWT

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA - B1130S0SS081300 Catalog Number : 0S0SS08130

Device Description : Shoulder Innovations TSA. Humeral Stem. 8mm x 130mm. Cobalt Chrome.

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : HSD, KWS, KWT

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA - B1130S0SS101300 Catalog Number : 0S0SS10130

Device Description : Shoulder Innovations TSA. Humeral Stem. 10mm x 130mm. Cobalt Chrome.

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : HSD, KWS, KWT

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA - B1130S0SS121300 Catalog Number : 0S0SS12130

Device Description : Shoulder Innovations TSA. Humeral Stem. 12mm x130mm. Cobalt Chrome.

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA - B1130S0SS141300 Catalog Number : 0S0SS14130

Device Description : Shoulder Innovations TSA. Humeral Stem. 14mm x 130mm. Cobalt Chrome.

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : HSD, KWT, KWS

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1CI220060 Catalog Number : 0S1CI22006

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1CI220080 Catalog Number : 0S1CI22008

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

Shoulder Innovations TSA System - B1130S1CI240060 Catalog Number : 0S1CI24006

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1CI240080 Catalog Number : 0S1CI24008

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

SHOULDER INNOVATIONS TSA SYSTEM - B1130S1CI270060 Catalog Number : 0S1CI27006

Device Class : 2

Duns Number: 080404519

Premarket Exempt : No

Product Code : KWS, KWT, HSD

Prescription Use : Yes

Device Count : 1

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