"1.5" SYSTEM 01-7186

GUDID 00841036013394

BIOMET MICROFIXATION, INC

Orthopaedic implant/trial-implant holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00841036013394
• NIH Device Record Key: 874f4fb4-515d-4c48-a7b0-21c3244e871a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "1.5" SYSTEM
• Version Model Number: 01-7186
• Catalog Number: 01-7186
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036013394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

[00841036013394]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

Devices Manufactured by BIOMET MICROFIXATION, INC

• 00888233069373 - Sternalock EZ, Box Junction Plate, 10 Holes: 2024-04-02
• 00888233069380 - Sternalock EZ, O Junction Plate, 12 Holes: 2024-04-02
• 00888233069434 - Sternalock EZ, O Plate, 6 Holes: 2024-04-02
• 00888233069441 - 18mm Locking Screw: 2024-04-02
• 00888233069458 - 14mm Locking Screw: 2024-04-02
• 00888233069595 - Sternalock EZ, V Plate, 4 Holes: 2024-04-02
• 00888233069601 - Sternalock EZ, H Plate, 6 Holes: 2024-04-02
• 00888233069618 - Sternalock EZ, V Junction Plate, 10 Holes: 2024-04-02