VariAx 657108

GUDID 07613327069501

Bone Screw, Fully Threaded,T10

Stryker Trauma SA

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 07613327069501
• NIH Device Record Key: 7c3d2cf1-6428-4765-a43e-100a0887fc0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VariAx
• Version Model Number: 657108
• Catalog Number: 657108
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: 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 Dimensions

• Length: 8 Millimeter
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327069501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180500

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

[07613327069501]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-26
• Device Publish Date: 2015-09-24

On-Brand Devices [VariAx]

• 07613327379426: Bone Screw, T5
• 07613327379419: Bone Screw, T5
• 07613327379402: Bone Screw, T5
• 07613327379396: Bone Screw, T5
• 07613327379389: Bone Screw, T5
• 07613327379372: Bone Screw, T5
• 07613327379365: Bone Screw, T5
• 37613327379175: Bone Screw, T6
• 07613327379167: Locking Screw, T6
• 37613327379151: Locking Screw, T6
• 07613327379143: Bone Screw, T5
• 07613327379136: Bone Screw, T6
• 37613327379120: Bone Screw, T5
• 07613327379112: Bone Screw, T5
• 07613327379105: Locking Screw, T6
• 07613327379099: Bone Screw, T6
• 07613327379082: Bone Screw, T6
• 37613327379076: Locking Screw, T6
• 07613327379068: Bone Screw, T6
• 07613327379051: Bone Screw, T6
• 07613327379044: Locking Screw, T6
• 07613327379037: Bone Screw, T5
• 07613327379020: Locking Screw, T6
• 07613327379013: Locking Screw, T6
• 07613327379006: Locking Screw, T6
• 07613327378993: Bone Screw, T6
• 07613327378986: Bone Screw, T6
• 37613327378970: Locking Screw, T6
• 07613327378962: Locking Screw, T5
• 37613327378956: Bone Screw, T5
• 07613327378948: Bone Screw, T6
• 07613327378931: Emerg. Screw, T6
• 07613327378924: Locking Screw, T5
• 07613327378917: Bone Screw, T6
• 07613327378900: Locking Screw, T5
• 07613327378894: Locking Screw, T5
• 07613327378887: Emerg. Screw, T5
• 07613327378870: Bone Screw, T5
• 07613327378863: Emerg. Screw, T5
• 07613327378856: Locking Screw, T5
• 07613327378849: Locking Screw, T5
• 07613327378832: Locking Screw, T5
• 07613327378825: Bone Screw, T6
• 07613327378818: Bone Screw, T6
• 07613327378801: Locking Screw, T5
• 07613327378795: Washer for 1.7mm Bone Screws
• 37613327378789: Locking Screw, T6
• 07613327378771: Emerg. Screw, T6
• 07613327378764: Bone Screw, T5
• 37613327378758: Locking Screw, T6