Shoulder Innovations InSet 70 Humeral Stem 2L1S140000

GUDID B1132L1S1400000

Shoulder Innovations - InSet 70 Humeral Stem - 14x70mm

Shoulder Innovations, Inc.

Total shoulder prosthesis
Primary Device IDB1132L1S1400000
NIH Device Record Keya72fe4b0-53e4-4c25-a0f6-376535d37e7f
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations InSet 70 Humeral Stem
Version Model Number14x70mm
Catalog Number2L1S140000
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
HIBCCB1132L1S1400000 [Primary]

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation Sterilization

[B1132L1S1400000]

Radiation 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
B1132L2HS700050Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Starter Awl
B1132L2HS700040Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Box Osteotome
B1132L2HG700380Shoulder Innovations - InSet 70 Humeral Stem - Instrument: Alignment Guide
B1130S1GK000030Shoulder Innovations - InSet 70 Humeral Stem - Instrument: K-Wire, 2.4mm x 90mm
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