Knochenschrauben

GUDID 04026575273805

WALDEMAR LINK GmbH & Co. KG

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 04026575273805
• NIH Device Record Key: 77c9641d-75ec-4d67-967c-a60f829a2639
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knochenschrauben
• Version Model Number: 180-658/80
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: 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	04026575273805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192559

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2023-01-25

On-Brand Devices [Knochenschrauben]

• 04026575427437: 180-658/40
• 04026575427420: 180-658/35
• 04026575427413: 180-658/30
• 04026575427406: 180-658/25
• 04026575427390: 180-658/20
• 04026575427376: 180-658/15
• 04026575273805: 180-658/80
• 04026575273799: 180-658/70
• 04026575273782: 180-658/60
• 04026575273775: 180-658/55
• 04026575273768: 180-658/50
• 04026575273751: 180-658/45