2.7MM SYSTEM SP-2843

GUDID 00841036152710

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036152710
• NIH Device Record Key: b9563e31-77e2-4758-b2ec-5cb0dc78ab3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.7MM SYSTEM
• Version Model Number: SP-2843
• Catalog Number: SP-2843
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036152710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854886

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

Moist Heat or Steam Sterilization

[00841036152710]

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 [2.7MM SYSTEM]

• 00841036152710: SP-2843
• 00841036152697: SP-2842
• 00841036065638: CROSS-DRIVE EMERGENCY SCREW 3.2X16MM
• 00841036058579: CROSS-DRIVE EMERGENCY SCREW 3.2X12MM
• 00841036058562: CROSS-DRIVE EMERGENCY SCREW 3.2X10MM
• 00841036058555: CROSS-DRIVE EMERGENCY SCREW 3.2X8MM
• 00841036018399: DRILL 2.0X105MM 75MM STP J-NT
• 00841036018382: DRILL 2.0X70MM 40MM STP J-NT
• 00888233019231: SP-2843
• 00888233019217: SP-2842