IO Freedom

GUDID 00842078121139

4.5 x 38mm - Long Thread

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078121139
• NIH Device Record Key: a06598bd-ecf2-4311-a8c2-96292bcd6de5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IO Freedom
• Version Model Number: 118-45238
• 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	00842078121139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201556

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

[00842078121139]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [IO Freedom]

• 00842078129708: 6.5 x 110mm - Long Thread
• 00842078129692: 6.5 x 105mm - Long Thread
• 00842078129685: 6.5 x 100mm - Long Thread
• 00842078121917: 3.5 x 50mm - Short Thread
• 00842078121887: 3.5 x 45mm - Short Thread
• 00842078121856: 3.5 x 40mm - Short Thread
• 00842078121849: 3.5 x 38mm - Short Thread
• 00842078121832: 3.5 x 36mm - Short Thread
• 00842078121825: 3.5 x 34mm - Short Thread
• 00842078121818: 3.5 x 32mm - Short Thread
• 00842078121801: 3.5 x 30mm - Short Thread
• 00842078121795: 3.5 x 28mm - Short Thread
• 00842078121788: 3.5 x 26mm - Short Thread
• 00842078121771: 3.5 x 24mm - Short Thread
• 00842078121764: 3.5 x 22mm - Short Thread
• 00842078121757: 3.5 x 20mm - Short Thread
• 00842078121740: 3.5 x 50mm - Long Thread
• 00842078121719: 3.5 x 45mm - Long Thread
• 00842078121689: 3.5 x 40mm - Long Thread
• 00842078121672: 3.5 x 38mm - Long Thread
• 00842078121665: 3.5 x 36mm - Long Thread
• 00842078121658: 3.5 x 34mm - Long Thread
• 00842078121641: 3.5 x 32mm - Long Thread
• 00842078121634: 3.5 x 30mm - Long Thread
• 00842078121566: 6.5mm Screw Washer
• 00842078121559: 3.5mm Screw Washer
• 00842078121429: 6.5 x 95mm - Long Thread
• 00842078121412: 6.5 x 90mm - Long Thread
• 00842078121405: 6.5 x 85mm - Long Thread
• 00842078121399: 6.5 x 80mm - Long Thread
• 00842078121382: 6.5 x 75mm - Long Thread
• 00842078121375: 6.5 x 70mm - Long Thread
• 00842078121368: 6.5 x 65mm - Long Thread
• 00842078121351: 6.5 x 60mm - Long Thread
• 00842078121344: 6.5 x 55mm - Long Thread
• 00842078121337: 6.5 x 50mm - Long Thread
• 00842078121320: 6.5 x 45mm - Long Thread
• 00842078121313: 6.5 x 40mm - Long Thread
• 00842078121306: 6.5 x 45mm - Short Thread
• 00842078121290: 6.5 x 40mm - Short Thread
• 00842078121221: 4.5 x 60mm - Long Thread
• 00842078121214: 4.5 x 55mm - Long Thread
• 00842078121207: 4.5 x 50mm - Long Thread
• 00842078121177: 4.5 x 45mm - Long Thread
• 00842078121146: 4.5 x 40mm - Long Thread
• 00842078121139: 4.5 x 38mm - Long Thread
• 00842078121122: 4.5 x 36mm - Long Thread
• 00842078121108: 4.5 x 34mm - Long Thread
• 00842078121092: 4.5 x 32mm - Long Thread
• 00842078121085: 4.5 x 30mm - Long Thread