1895-5105S

GUDID 04546540202246

Condyle Screw

Stryker Trauma GmbH

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 04546540202246
• NIH Device Record Key: 682e2fd3-f809-4784-a536-e3ce6d72599b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1895-5105S
• Catalog Number: 1895-5105S
• 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 Dimensions

• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0
• Length: 105 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540202246 [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