SPACER W/BOLT 10492

GUDID 00887868001550

Biomet Orthopedics, LLC

External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use

• Primary Device ID: 00887868001550
• NIH Device Record Key: 00514546-1ee1-48f2-a2cb-34ea173041fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPACER W/BOLT
• Version Model Number: 10492
• Catalog Number: 10492
• 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: 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

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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868001550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112218
• Premarket Notification: K860018

FDA Product Code

• HXK: HOLDER, NEEDLE; ORTHOPEDIC

Sterilization

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

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

[00887868001550]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SPACER W/BOLT]

• 00887868001567: 10495
• 00887868001550: 10492