1895-5001S

GUDID 04546540202109

Condyle Screw Nut

Stryker Trauma GmbH

Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut Orthopaedic bone nut

• Primary Device ID: 04546540202109
• NIH Device Record Key: a618b10a-af25-476a-87aa-f9c0f31fa8cf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1895-5001S
• Catalog Number: 1895-5001S
• Company DUNS: 330211587
• Company Name: Stryker Trauma GmbH
• 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: 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	04546540202109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014220

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 2015-09-24

Devices Manufactured by Stryker Trauma GmbH

• 07613327376210 - T2 ALPHA: 2023-12-21 Locking Scalpel
• 07613327361797 - T2 ALPHA: 2023-06-02 Guide Wire with Ruler Tube
• 07613327361803 - T2 ALPHA: 2023-06-02 Guide Wire with Ruler Tube
• 07613327406153 - T2 ALPHA: 2023-06-02 Guide Wire
• 07613327406184 - T2 ALPHA: 2023-06-02 Guide Wire
• 07613327095548 - T2: 2022-05-05 Tibia System Magnetic Trigger
• 07613153179443 - T2: 2022-02-08 Locking Screw, Fully Threaded
• 04546540202475 - T2: 2022-02-04 Locking Screw, Fully Threaded