Shoulder Innovations InSet 70 Humeral Stem 2L2HI00004

GUDID B1132L2HI000040

Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Impaction Stand Adapter

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device IDB1132L2HI000040
NIH Device Record Key5ad4f09c-5e5c-4875-a8dc-5d68d68e0647
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations InSet 70 Humeral Stem
Version Model Number70mm Stem Adapter
Catalog Number2L2HI00004
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
Phone616-294-1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132L2HI000040 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

[B1132L2HI000040]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-06
Device Publish Date2025-05-29

On-Brand Devices [Shoulder Innovations InSet 70 Humeral Stem]

B1132L2HI000040Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Impaction Stand Adapter
B1132L1S1400000Shoulder Innovations - InSet 70 Humeral Stem - 14x70mm
B1132L1S1200000Shoulder Innovations - InSet 70 Humeral Stem - 12x70mm
B1132L1S1000000Shoulder Innovations - InSet 70 Humeral Stem - 10x70mm
B1132L1S0800000Shoulder Innovations - InSet 70 Humeral Stem - 8x70mm
B1132L1S0600000Shoulder Innovations - InSet 70 Humeral Stem - 6x70mm
B1132L1S0400000Shoulder Innovations - InSet 70 Humeral Stem - 4x70mm
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