5.5MM ALLTHREAD(TM) ANCHOR FIXED 905958

GUDID 00880304464865

Biomet Orthopedics, LLC

Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable Bone tap, reusable

• Primary Device ID: 00880304464865
• NIH Device Record Key: 60687c37-3e65-4b82-a0ac-129f5392bed1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5.5MM ALLTHREAD(TM) ANCHOR FIXED
• Version Model Number: 905958
• Catalog Number: 905958
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304464865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193402

FDA Product Code

• HWC: Screw, fixation, bone
• HWX: TAP, BONE

Sterilization

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

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

[00880304464865]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-04-23
• Device Publish Date: 2017-07-28

Devices Manufactured by Biomet Orthopedics, LLC

• 00887868004087 - PRIMARY TREPHINE: 2024-04-03
• 00887868004094 - BUSHING: 2024-04-03
• 00887868004100 - SECONDARY TREPHINE: 2024-04-03
• 00887868048272 - TREPHINE: 2024-04-03
• 00887868048289 - TREPHINE: 2024-04-03
• 00887868048296 - TREPHINE: 2024-04-03
• 00887868048302 - TREPHINE: 2024-04-03
• 00880304658387 - Compress®: 2024-03-11