Helical Ridge

GUDID M970140015047500

4.75MM X 15MM PEEK Interference Screw

Medshape, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M970140015047500
• NIH Device Record Key: d4b330f8-d65b-44b0-b2bd-dff80b153aab
• Commercial Distribution Discontinuation: 2023-06-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Helical Ridge
• Version Model Number: 1400-15-0475
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
HIBCC	M970140015047500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141290

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2023-06-27
• Device Publish Date: 2017-02-13

On-Brand Devices [Helical Ridge]

• M97024000502006: Quick Connect Driver, 2.0 Reverse Threaded
• M970140020047500: 4.75MM X 20MM PEEK Interference Screw
• M970140017047500: 4.75MM X 17.5MM PEEK Interference Screw
• M970140015047500: 4.75MM X 15MM PEEK Interference Screw