"2.0" SYSTEM 95-2307

GUDID 00841036056414

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036056414
• NIH Device Record Key: abda1b85-fe12-4d77-b387-3aa65b018f8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "2.0" SYSTEM
• Version Model Number: 95-2307
• Catalog Number: 95-2307
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036056414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

Moist Heat or Steam Sterilization

[00841036056414]

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: 2015-10-11

On-Brand Devices ["2.0" SYSTEM]

• 00841036016777: 01-9086
• 00841036150754: 95-2304
• 00841036150747: 91-2304
• 00841036075941: 95-2317
• 00841036074005: 91-2029
• 00841036072179: 95-2315
• 00841036063726: 91-2313
• 00841036063719: 91-2317
• 00841036060213: 91-2315
• 00841036060190: 91-2311
• 00841036056445: 95-2313
• 00841036056438: 95-2311
• 00841036056421: 95-2309
• 00841036056414: 95-2307
• 00841036056407: 95-2305
• 00841036056360: 95-2019
• 00841036056353: 95-2017
• 00841036056346: 95-2015
• 00841036056339: 95-2013
• 00841036056322: 95-2011
• 00841036056315: 95-2009
• 00841036056308: 95-2007
• 00841036056292: 95-2005
• 00841036056285: 95-2004
• 00841036053505: 91-2309
• 00841036053451: 91-2021
• 00841036053444: 91-2019
• 00841036053420: 91-2015
• 00841036053413: 91-2013
• 00841036053406: 91-2011
• 00841036053390: 91-2009
• 00841036053369: 91-2004
• 00888233001588: 95-2304
• 00888233001434: 91-2304