Humelock II Cemented Shoulder System 926-0010

GUDID 03701037304754

HUMELOCK II TRIAL STEM T10

FX SOLUTIONS

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 03701037304754
• NIH Device Record Key: 69577c44-a621-4ed9-a572-306a80a5f9aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock II Cemented Shoulder System
• Version Model Number: 926-0010
• Catalog Number: 926-0010
• 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: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701037304754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123814

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Sterilization

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

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

[03701037304754]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-07
• Device Publish Date: 2017-12-14

On-Brand Devices [Humelock II Cemented Shoulder System]

• 03701037307199: CANNULATED HEX 3.5 SCREW DRIVER
• 03701037307182: HUMELOCK AIMING GUIDE SCREW
• 03701037307168: TRAUMA IMPACTOR
• 03701037307137: OSTEOTOME
• 03701037307106: HUMELOCK HEIGHT GAUGE AXIS POINT
• 03701037306864: HUMELOCK ANCHORING PLATE IMPACTOR HANDLE
• 03701037306857: HUMELOCK HEAD IMPACTOR BIT
• 03701037306840: HUMELOCK HEAD IMPACTOR HANDLE
• 03701037306833: STABILIZATION POST FORCEPS
• 03701037306826: STABILIZATION POST
• 03701037306819: GLENOID REMOVAL
• 03701037306796: DRILL BIT Ø4.5mm L150mm/ AO
• 03701037306765: GLENOID RESURFACING REAMER Ø39 mm/30 /AO
• 03701037306758: GLENOID RESURFACING REAMER Ø35 mm/30 /AO
• 03701037306741: GLENOID RESURFACING REAMER Ø31 mm/30 /AO
• 03701037306734: GLENOID RESURFACING REAMER Ø27 mm/30 /AO
• 03701037306536: HEX 3,5mm KEY
• 03701037306529: SCREW / RASP HANDLE
• 03701037306512: RASP HANDLE
• 03701037306468: STABILIZATION POST Ø7.5
• 03701037306451: HUMELOCK STAINLESS STEEL RULER L.150
• 03701037306444: HUMELOCK CORTICAL SCREW GAUGE
• 03701037306383: STOP DRILL BIT Ø7.5mm L.150
• 03701037305805: HEAD IMPACTOR
• 03701037305799: TAPER IMPACTOR
• 03701037305782: Ø34 IMPACTOR BIT
• 03701037305775: PUNCHER Ø38mm
• 03701037305768: PUNCHER Ø34mm
• 03701037305751: PUNCHER Ø30mm
• 03701037305744: K-WIRE CENTER GUIDE Ø50 mm
• 03701037305737: K-WIRE CENTER GUIDE Ø46 mm
• 03701037305720: K-WIRE CENTER GUIDE Ø43 mm
• 03701037305713: K-WIRE CENTER GUIDE Ø39 mM
• 03701037305706: EASYTECH SUPERIOR LATERAL CUTTING GUIDE
• 03701037305690: EASYTECH LEFT DELTO PECTORAL CUTTING GUIDE
• 03701037305683: EASYTECH RIGHT DELTO PECTORAL CUTTING GUIDE
• 03701037305676: CENTERING GUIDE
• 03701037305669: K-WIRE GUIDE HANDLE
• 03701037305652: RING CUTTING GUIDE Ø50 mm
• 03701037305645: RING CUTTING GUIDE Ø46 mm
• 03701037305638: RING CUTTING GUIDE Ø43 mm
• 03701037305621: RING CUTTING GUIDE Ø39 mm
• 03701037305591: CUTTING GUIDE HANDLE
• 03701037305560: CUTTING GUIDE SCREW
• 03701037305553: HUMELOCK HEX 6/3.5mmSCREWDRIVER
• 03701037305515: HUMELOCK HEIGHT GAUGE SUPERIOR FLAT
• 03701037305508: THREADED K-WIRE Ø2.0 L180mm
• 03701037305492: K-WIRE Ø2.0mm L.180mm
• 03701037304808: HUMELOCK II TRIAL STEM T15
• 03701037304792: HUMELOCK II TRIAL STEM T14