Humelock Reversed Shoulder 106-5200

GUDID 03701037303764

OFFSET HEAD CrCo 52x21

FX SOLUTIONS

Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis Stem-fixed humeral head prosthesis

• Primary Device ID: 03701037303764
• NIH Device Record Key: d93e9f69-803b-4f9c-88d1-4a3c193c9181
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humelock Reversed Shoulder
• Version Model Number: 106-5200
• Catalog Number: 106-5200
• 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	03701037303764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162455

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-08
• Device Publish Date: 2017-01-31

On-Brand Devices [Humelock Reversed Shoulder]

• 03701037307229: HUMELOCK REVERSED EXTRACTOR
• 03701037307205: HUMELOCK REVERSED CUTTING GUIDES HOLDER SCREW
• 03701037306390: SHORT T-HANDLE / AO
• 03701037306376: SPACER TRIAL +9 mm
• 03701037306369: HUMELOCK REVERSED EPIPHYSEAL RASP Ø40mm
• 03701037306352: HUMELOCK REVERSED EPIPHYSEAL RASP Ø36mm
• 03701037306345: HUMELOCK REVERSED EPIPHYSEAL RASP Ø32mm
• 03701037306338: HUMELOCK REVERSED METAPHYSEAL RASP Ø40mm
• 03701037306321: HUMELOCK REVERSED METAPHYSEAL RASP Ø36mm
• 03701037306314: HUMELOCK REVERSED METAPHYSEAL RASP Ø32mm
• 03701037306307: HUMELOCK REVERSED WRENCH
• 03701037306291: HUMELOCK REVERSED REAMER Ø20mm
• 03701037306284: HUMELOCK REVERSED REAMER Ø18mm
• 03701037306277: HUMELOCK REVERSED REAMER Ø16mm
• 03701037306260: HUMELOCK REVERSED REAMER Ø15mm
• 03701037306253: HUMELOCK REVERSED REAMER Ø14mm
• 03701037306246: HUMELOCK REVERSED REAMER Ø13mm
• 03701037306239: HUMELOCK REVERSED REAMER Ø12mm
• 03701037306222: HUMELOCK REVERSED REAMER Ø11mm
• 03701037306215: HUMELOCK REVERSED REAMER Ø10mm
• 03701037306208: HUMELOCK REVERSED REAMER Ø9mm
• 03701037306192: HUMELOCK REVERSED REAMER Ø8mm
• 03701037306185: HUMELOCK REVERSED T HANDLE / AO
• 03701037306178: HUMELOCK REVERSED TRIANGULAR AWL
• 03701037306161: RATCHET HANDLE
• 03701037306116: INFERIOR GLENOID RETRACTOR
• 03701037306109: SUPERIOR GLENOID RETRACTOR
• 03701037306093: ANTERIOR GLENOID RETRACTOR
• 03701037306086: DRILL BIT Ø07mm / AO EXT. POST +10mm
• 03701037306079: DRILL BIT Ø07mm / AO EXT. POST +6mm
• 03701037306062: HUMELOCK REVERSED GLENOSPHERE CLAMP DELTO PECTORAL
• 03701037306055: HUMELOCK REVERSED GLENOSPHERE HOLDER
• 03701037306048: EXTENSION
• 03701037306031: HUMELOCK REVERSED PIN EXTRACTOR
• 03701037306024: HUMELOCK REVERSED HAMMER
• 03701037306017: HUMELOCK REVERSED ARCH Ø40
• 03701037306000: HUMELOCK REVERSED ARCH Ø36
• 03701037305997: HUMELOCK REVERSED GLENOID MANUAL REAMER Ø36mm
• 03701037305980: GLENOID RESURFACING REAMER Ø36 mm/ AO
• 03701037305973: GLENOID RESURFACING REAMER Ø40 mm/ AO
• 03701037305966: DRILL BIT Ø3.2 mm L.250mm/AO
• 03701037305935: HUMELOCK REVERSED SCREW / AIMER
• 03701037305928: HUMELOCK REVERSED AIMER
• 03701037305911: HUMELOCK REVERSED BASE PLATE IMPACTOR
• 03701037305904: HUMELOCK REVERSED GLENOID MANUAL REAMER Ø40mm
• 03701037305898: HUMELOCK REVERSED GLENOID RESURFACING REAMER Ø24mm / AO
• 03701037305881: HUMELOCK REVERSED GUIDES HOLDER
• 03701037305867: HUMELOCK REVERSED END ROD CUP IMPACTOR
• 03701037305850: HUMELOCK REVERSED HANDLE CUP IMPACTOR
• 03701037305843: HUMELOCK REVERSED STEM IMPACTOR