Humelock II Cemented Reversible Shoulder

GUDID 03701037302255

STANDARD SCREW TA6V Ø4.5mm L.40mm

FX SOLUTIONS

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 03701037302255
• NIH Device Record Key: e98596f5-9490-496b-b974-95e2362350c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock II Cemented Reversible Shoulder
• Version Model Number: 109-4540
• Company DUNS: 263076196
• Company Name: FX SOLUTIONS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037302255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150488

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

On-Brand Devices [Humelock II Cemented Reversible Shoulder]

• 03701037306406: DEGENERATIVE IMPACTOR
• 03701037303559: TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +9
• 03701037303542: TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +6
• 03701037303535: TRIAL HUMERAL CUP 135/145° STANDARD Ø40 +3
• 03701037303528: TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +9
• 03701037303511: TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +6
• 03701037303504: TRIAL HUMERAL CUP 135/145° STANDARD Ø36 +3
• 03701037303498: TRIAL HUMERAL CUP 135/145° Ø40+9
• 03701037303481: TRIAL HUMERAL CUP 135/145° Ø40+6
• 03701037303474: TRIAL HUMERAL CUP 135/145° Ø40+3
• 03701037303467: TRIAL ECCENTRIC GLENOSPHERE Ø40
• 03701037303450: TRIAL CENTERED GLENOSPHERE Ø40
• 03701037303443: TRIAL ECCENTRIC GLENOSPHERE Ø36
• 03701037303436: TRIAL CENTERED GLENOSPHERE Ø36
• 03701037303375: STANDARD TRIAL CUP Ø36 + 9
• 03701037303368: STANDARD TRIAL CUP Ø36 + 6
• 03701037303351: STANDARD TRIAL CUP Ø36 + 3
• 03701037302927: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +9
• 03701037302910: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +6
• 03701037302903: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø40 +3
• 03701037302897: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +9
• 03701037302880: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +6
• 03701037302873: HUMERAL CUP 135/145° MOBILITY PE/TA6V Ø36 +3
• 03701037302866: HUMERAL CUP MOBILITY PE/TA6V Ø40/+9
• 03701037302859: HUMERAL CUP MOBILITY PE/TA6V Ø40/+6
• 03701037302842: HUMERAL CUP MOBILITY PE/TA6V Ø40/+3
• 03701037302835: HUMERAL CUP MOBILITY PE/TA6V Ø36/+9
• 03701037302828: HUMERAL CUP MOBILITY PE/TA6V Ø36/+6
• 03701037302811: HUMERAL CUP MOBILITY PE/TA6V Ø36/+3
• 03701037302637: STANDARD SCREW TA6V Ø4.5mm L.48 mm
• 03701037302620: STANDARD SCREW TA6V Ø4.5mm L.46 mm
• 03701037302613: STANDARD SCREW TA6V Ø4.5mm L.44 mm
• 03701037302583: STANDARD SCREW TA6V Ø4.5mm L.36 mm
• 03701037302569: STANDARD SCREW TA6V Ø4.5mm L.32 mm
• 03701037302552: STANDARD SCREW TA6V Ø4.5mm L.28 mm
• 03701037302545: STANDARD SCREW TA6V Ø4.5mm L.26 mm
• 03701037302538: STANDARD SCREW TA6V Ø4.5mm L.24 mm
• 03701037302521: STANDARD SCREW TA6V Ø4.5mm L.22 mm
• 03701037302477: LOCKING SCREW TA6V Ø4.5mm L.48 mm
• 03701037302460: LOCKING SCREW TA6V Ø4.5mm L.46 mm
• 03701037302453: LOCKING SCREW TA6V Ø4.5mm L.44 mm
• 03701037302446: LOCKING SCREW TA6V Ø4.5mm L.42 mm
• 03701037302439: LOCKING SCREW TA6V Ø4.5mm L.38 mm
• 03701037302422: LOCKING SCREW TA6V Ø4.5mm L.36mm
• 03701037302415: LOCKING SCREW TA6V Ø4.5mm L.34 mm
• 03701037302408: LOCKING SCREW TA6V Ø4.5mm L.32 mm
• 03701037302392: LOCKING SCREW TA6V Ø4.5mm L.28 mm
• 03701037302385: LOCKING SCREW TA6V Ø4.5mm L.26 mm
• 03701037302378: LOCKING SCREW TA6V Ø4.5mm L.24 mm
• 03701037302361: LOCKING SCREW TA6V Ø4.5mm L.22 mm