DFS XS FIXATOR 02570

GUDID 00887868081583

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: 00887868081583
• NIH Device Record Key: b66287ac-9173-41bb-95ca-0d692555cbc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DFS XS FIXATOR
• Version Model Number: 02570
• Catalog Number: 02570
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868081583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000319
• Premarket Notification: K953406

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

Moist Heat or Steam Sterilization

[00887868081583]

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 [DFS XS FIXATOR]

• 00888480104421: 02540
• 00887868081583: 02570
• 00887868081576: 02565
• 00887868081569: 02564
• 00887868081552: 02560
• 00887868081538: 02545
• 00887868081514: 02535
• 00887868081507: 02530
• 00887868081491: 02525
• 00887868081484: 02520
• 00887868081477: 02510
• 00887868081460: 02509
• 00887868081453: 02508
• 00887868081446: 02507
• 00887868081439: 02505
• 00887868081422: 02500