234-010-055

GUDID 04546540754554

UNIVERSAL WEDGE 9MM X 20MM (1.5MM BORE)

STRYKER CORPORATION

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 04546540754554
• NIH Device Record Key: 97c1eba6-73ec-491b-b5b8-7e95d303a8a9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 234-010-055
• Catalog Number: 234-010-055
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx
• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Lumen/Inner Diameter: 1.5 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540754554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972233

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-09

Devices Manufactured by STRYKER CORPORATION

• B235MDK00020 - mild Device Kit: 2025-08-07
• 07613327262995 - XIA II: 2025-07-17 CORONAL BENDER LEFT
• 07613327263015 - XIA II: 2025-07-17 CORONAL BENDER RIGHT
• 07613327661989 - KNOTILUS+: 2025-06-24 2.9X15.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327661996 - KNOTILUS+: 2025-06-24 2.4X8.9MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662009 - KNOTILUS+: 2025-06-24 2.4X11.3MM KNOTILUS+ ANCHOR - BIOCOMPOSITE
• 07613327662016 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ HIP ANCHOR - BIOCOMPOSITE
• 07613327662023 - KNOTILUS+: 2025-06-24 2.9X12.5MM KNOTILUS+ ANCHOR - BIOCOMPOSITE