Shoulder Innovations InSet 95 Humeral Stem 2L2HB00010

GUDID B1132L2HB000100

Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 10mm Stem Broach

Shoulder Innovations, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: B1132L2HB000100
• NIH Device Record Key: 4229e714-327b-481e-9dd5-54adb6449026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shoulder Innovations InSet 95 Humeral Stem
• Version Model Number: 10mm Stem Broach
• Catalog Number: 2L2HB00010
• 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
• Phone: 616-294-1026
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B1132L2HB000100 [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

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

[B1132L2HB000100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-12-07
• 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
• B1132L2HT000010: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Generic Jacobs Hall Silicone T Handl
• B1132L2HT000000: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Generic Jacobs Hall T Handle
• B1132L2HS000160: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 16mm Reamer Sounder
• B1132L2HS000140: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 14mm Reamer Sounder
• B1132L2HS000120: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 12mm Reamer Sounder
• B1132L2HS000100: Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 10mm Reamer Sounder