Axis

GUDID 00842078113806

Fixation Beam, 8.5 x 85 mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078113806
• NIH Device Record Key: ee1654cb-d8f6-4a91-ab38-7aa22c4b2c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axis
• Version Model Number: 130-85085
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00842078113806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171018

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078113806]

Moist Heat or Steam Sterilization

[00842078113806]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-04
• Device Publish Date: 2019-06-26

On-Brand Devices [Axis]

• 00842078113295: Fixation Beam, 6.5 x 120 mm
• 00842078113288: Fixation Beam, 6.5 x 115 mm
• 00842078113271: Fixation Beam, 6.5 x 110 mm
• 00842078113264: Fixation Beam, 6.5 x 105 mm
• 00842078113257: Fixation Beam, 6.5 x 100 mm
• 00842078113240: Fixation Beam, 6.5 x 95 mm
• 00842078113233: Fixation Beam, 6.5 x 90 mm
• 00842078113226: Fixation Beam, 6.5 x 85 mm
• 00842078113219: Fixation Beam, 6.5 x 80 mm
• 00842078113202: Fixation Beam, 6.5 x 75 mm
• 00842078113196: Fixation Beam, 6.5 x 70 mm
• 00842078113189: Fixation Beam, 6.5 x 65 mm
• 00842078113172: Fixation Beam, 6.5 x 60 mm
• 00842078113165: Fixation Beam, 6.5 x 55 mm
• 00842078113158: Fixation Beam, 6.5 x 50 mm
• 00842078113141: Fixation Beam, 6.5 x 45 mm
• 00842078113134: Fixation Beam, 6.5 x 40 mm
• 00842078113080: Fixation Beam, 5.5 x 150 mm
• 00842078113073: Fixation Beam, 5.5 x 145 mm
• 00842078113066: Fixation Beam, 5.5 x 140 mm
• 00842078113059: Fixation Beam, 5.5 x 135 mm
• 00842078113042: Fixation Beam, 5.5 x 130 mm
• 00842078113035: Fixation Beam, 5.5 x 125 mm
• 00842078113028: Fixation Beam, 5.5 x 120 mm
• 00842078113011: Fixation Beam, 5.5 x 115 mm
• 00842078113004: Fixation Beam, 5.5 x 110 mm
• 00842078112991: Fixation Beam, 5.5 x 105 mm
• 00842078112984: Fixation Beam, 5.5 x 100 mm
• 00842078112977: Fixation Beam, 5.5 x 95 mm
• 00842078112960: Fixation Beam, 5.5 x 90 mm
• 00842078112953: Fixation Beam, 5.5 x 85 mm
• 00842078112946: Fixation Beam, 5.5 x 80 mm
• 00842078112939: Fixation Beam, 5.5 x 75 mm
• 00842078112922: Fixation Beam, 5.5 x 70 mm
• 00842078112915: Fixation Beam, 5.5 x 65 mm
• 00842078112908: Fixation Beam, 5.5 x 60 mm
• 00842078112892: Fixation Beam, 5.5 x 55 mm
• 00842078112885: Fixation Beam, 5.5 x 50 mm
• 00842078112878: Fixation Beam, 5.5 x 45 mm
• 00842078112861: Fixation Beam, 5.5 x 40 mm
• 00842078112816: Fixation Beam, 4.5 x 150 mm
• 00842078112809: Fixation Beam, 4.5 x 145 mm
• 00842078112793: Fixation Beam, 4.5 x 140 mm
• 00842078112786: Fixation Beam, 4.5 x 135 mm
• 00842078112779: Fixation Beam, 4.5 x 130 mm
• 00842078112762: Fixation Beam, 4.5 x 125 mm
• 00842078112755: Fixation Beam, 4.5 x 120 mm
• 00842078112748: Fixation Beam, 4.5 x 115 mm
• 00842078112731: Fixation Beam, 4.5 x 110 mm
• 00842078112724: Fixation Beam, 4.5 x 105 mm