Paxeon Logical

GUDID 08177570201778

Cancellous Bone Screw Size 50mm

PAXEON RECONSTRUCTION LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08177570201778
• NIH Device Record Key: e64c9dfa-f704-475c-86e8-2efbe1af3803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paxeon Logical
• Version Model Number: PR111-12-9150
• Company DUNS: 080437990
• Company Name: PAXEON RECONSTRUCTION LLC
• 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: true
• 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	08177570201778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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: 2024-02-19
• Device Publish Date: 2016-12-14

On-Brand Devices [Paxeon Logical ]

• 08177570201341: Logical G-Series Shell – 3 Holes Size 68-E
• 08177570201334: Logical G-Series Shell – 3 Holes Size 66-E
• 08177570201327: Logical G-Series Shell – 3 Holes Size 64-E
• 08177570201310: Logical G-Series Shell – 3 Holes Size 62-E
• 08177570201303: Logical G-Series Shell – 3 Holes Size 60-E
• 08177570201297: Logical G-Series Shell – 3 Holes Size 58-D
• 08177570201280: Logical G-Series Shell – 3 Holes Size 56-D
• 08177570201273: Logical G-Series Shell – 3 Holes Size 54-C
• 08177570201266: Logical G-Series Shell – 3 Holes Size 52-C
• 08177570201259: Logical G-Series Shell – 3 Holes Size 50-B
• 08177570201242: Logical G-Series Shell – 3 Holes Size 48-B
• 08177570201235: Logical G-Series Shell – 3 Holes Size 46-A
• 08177570201228: Logical G-Series Shell – 3 Holes Size 44-A
• 08177570201815: Cancellous Bone Screw Size 70mm
• 08177570201808: Cancellous Bone Screw Size 65mm
• 08177570201792: Cancellous Bone Screw Size 60mm
• 08177570201785: Cancellous Bone Screw Size 55mm
• 08177570201778: Cancellous Bone Screw Size 50mm
• 08177570201761: Cancellous Bone Screw Size 45mm
• 08177570201754: Cancellous Bone Screw Size 40mm
• 08177570201747: Cancellous Bone Screw Size 35mm
• 08177570201723: Cancellous Bone Screw Size 25mm
• 08177570201716: Cancellous Bone Screw Size 20mm
• 08177570201709: Cancellous Bone Screw Size 15mm