SP 4035-45-2

GUDID 04042409398155

Cancellous Screw 4.0, small head, T15, full thread, L 45 Titanium

aap Implantate AG

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

• Primary Device ID: 04042409398155
• NIH Device Record Key: 6868b285-1968-444f-aa4e-1c7928d95818
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SP 4035-45-2
• Catalog Number: SP 4035-45-2
• Company DUNS: 328420633
• Company Name: aap Implantate AG
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04042409398155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182818

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[04042409398155]

Moist Heat or Steam Sterilization

[04042409398155]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

Devices Manufactured by aap Implantate AG

• 04042409047657 - NA: 2024-02-19 K-wire with trocar point, ø0.8, L 150
• 04042409047695 - NA: 2024-02-19 K-wire with trocar point, ø0.8, L 310
• 04042409047701 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 100
• 04042409047718 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 150
• 04042409047725 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 150
• 04042409047732 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 200
• 04042409047749 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 250
• 04042409047763 - NA: 2024-02-19 K-wire with trocar point, ø1.0, L 310