Shoulder Innovations IM Cut Guide 2R2HC00009

GUDID B1132R2HC000090

Shoulder Innovations - IM Cut Guide Instrument - Subscapularis Sparing Cut Guide Hanger

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132R2HC000090
NIH Device Record Keya9d9337b-4c16-469d-a1f9-35dab84cd54a
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations IM Cut Guide
Version Model NumberIM Cut Guide Subscapularis Sparing Cut Guide Hange
Catalog Number2R2HC00009
Company DUNS080404519
Company NameShoulder Innovations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com
Phone616-294-1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132R2HC000090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

[B1132R2HC000090]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-28
Device Publish Date2025-04-18

On-Brand Devices [Shoulder Innovations IM Cut Guide]

B1132R2HC000040Shoulder Innovations - IM Cut Guide - Instrument Delto-Pectoral Cut Guide
B1132R2HC000020Shoulder Innovations - IM Cut Guide - Instrument Delto-Pectoral Fixed Arm Assembly
B1132R2HC000010Shoulder Innovations - IM Cut Guide - Instrument T-Handle
B1132R2HC000090Shoulder Innovations - IM Cut Guide Instrument - Subscapularis Sparing Cut Guide Hanger
B1132R2HC000080Shoulder Innovations - IM Cut Guide Instrument - Subscapularis Sparing Cut Block Assembly
B1132R2HC000050Shoulder Innovations - IM Cut Guide Instrument - Superior-Lateral Fixed Arm Assembly
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