Shoulder Innovations InSet 95 Humeral Stem 2L2HI00002

GUDID B1132L2HI00002

Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Inserter

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132L2HI00002
• NIH Device Record Key: 8bcb6a82-2bcd-4f08-85a4-54ad29a75a7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations InSet 95 Humeral Stem
• Version Model Number: Inserter
• Catalog Number: 2L2HI00002
• Company DUNS: 080404519
• Company Name: Shoulder Innovations, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx
• Phone: 616-294-1026
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132L2HI00002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102670

FDA Product Code

• MBF: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

[B1132L2HI00002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-10
• Device Publish Date: 2023-11-02

On-Brand Devices [Shoulder Innovations InSet 95 Humeral Stem]

• B1132L1S1500010: Shoulder Innovations - InSet 95 Humeral Stem - 15x95mm
• B1132L1S1400010: Shoulder Innovations - InSet 95 Humeral Stem - 14x95mm
• B1132L1S1300010: Shoulder Innovations - InSet 95 Humeral Stem - 13x95mm
• B1132L1S1200010: Shoulder Innovations - InSet 95 Humeral Stem - 12x95mm
• B1132L1S1100010: Shoulder Innovations - InSet 95 Humeral Stem - 11x95mm
• B1132L1S1000010: Shoulder Innovations - InSet 95 Humeral Stem - 10x95mm
• B1132L1S0900010: Shoulder Innovations - InSet 95 Humeral Stem - 9x95mm
• B1132L1S0800010: Shoulder Innovations - InSet 95 Humeral Stem - 8x95mm
• B1132L1S0700010: Shoulder Innovations - InSet 95 Humeral Stem - 7x95mm
• B1132L1S0600010: Shoulder Innovations - InSet 95 Humeral Stem - 6x95mm
• B1132L1S0500010: Shoulder Innovations - InSet 95 Humeral Stem - 5x95mm
• B1132L1S0400010: Shoulder Innovations - InSet 95 Humeral Stem - 4x95mm
• B1132L2HI00003: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Impaction Stand
• B1132L2HI00002: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Inserter
• B1132L2HI00001: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Broach Handle
• B1132L2HB00015: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 15mm Stem Broach
• B1132L2HB00014: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 14mm Stem Broach
• B1132L2HB00013: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 13mm Stem Broach
• B1132L2HB00012: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 12mm Stem Broach
• B1132L2HB00011: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 11mm Stem Broach
• B1132L2HB00010: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 10mm Stem Broach
• B1132L2HB00009: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 9mm Stem Broach
• B1132L2HB00008: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 8mm Stem Broach
• B1132L2HB00007: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 7mm Stem Broach
• B1132L2HB00006: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 6mm Stem Broach
• B1132L2HB00005: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 5mm Stem Broach
• B1132L2HB00004: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 4mm Stem Broach
• B1132L2HI000030: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Impaction Stand
• B1132L2HI000020: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Inserter
• B1132L2HI000010: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Broach Handle
• B1132L2HB000150: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 15mm Stem Broach
• B1132L2HB000140: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 14mm Stem Broach
• B1132L2HB000130: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 13mm Stem Broach
• B1132L2HB000120: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 12mm Stem Broach
• B1132L2HB000110: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 11mm Stem Broach
• B1132L2HB000100: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 10mm Stem Broach
• B1132L2HB000090: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 9mm Stem Broach
• B1132L2HB000080: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 8mm Stem Broach
• B1132L2HB000070: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 7mm Stem Broach
• B1132L2HB000060: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 6mm Stem Broach
• B1132L2HB000050: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 5mm Stem Broach
• B1132L2HB000040: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 4mm Stem Broach
• B1132L2HC000000: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: InSet 95 Instrument Case
• B1132L2HI000100: Shoulder Innovations - InSet 95 Humeral Stem - Instrument Lever Lock Broach Handle