MANZA SCREWS 104-65-015

GUDID 00841176102118

MANZA TITANIUM CANCELLOUS SCREW 6.5 X 15 MM

STINSON ORTHOPEDICS INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00841176102118
• NIH Device Record Key: db366d60-5ba8-4343-8e04-4261b84d1e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANZA SCREWS
• Version Model Number: 104-65-015
• Catalog Number: 104-65-015
• Company DUNS: 080460688
• Company Name: STINSON ORTHOPEDICS 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: 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	00841176102118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-26

On-Brand Devices [MANZA SCREWS]

• 00841176102408: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 70 MM
• 00841176102392: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 65 MM
• 00841176102200: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 60 MM
• 00841176102194: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 55 MM
• 00841176102187: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 50 MM
• 00841176102170: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 45 MM
• 00841176102163: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 40 MM
• 00841176102156: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 35 MM
• 00841176102149: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 30 MM
• 00841176102132: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 25 MM
• 00841176102125: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 20 MM
• 00841176102118: MANZA TITANIUM CANCELLOUS SCREW 6.5 X 15 MM