"2.4MM" SYSTEM 95-2418

GUDID 00841036056513

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036056513
• NIH Device Record Key: 72e6646b-7135-4ef5-bdd4-d86d648d4280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "2.4MM" SYSTEM
• Version Model Number: 95-2418
• Catalog Number: 95-2418
• 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	00841036056513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001238

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

Moist Heat or Steam Sterilization

[00841036056513]

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 ["2.4MM" SYSTEM]

• 00841036150785: 95-2720
• 00841036082925: 91-2420
• 00841036056513: 95-2418
• 00841036056506: 95-2416
• 00841036056490: 95-2414
• 00841036056483: 95-2412
• 00841036056476: 95-2410
• 00841036056469: 95-2408
• 00841036056452: 95-2406
• 00841036053611: 91-2436
• 00841036053604: 91-2432
• 00841036053598: 91-2428
• 00841036053581: 91-2424
• 00841036053574: 91-2418
• 00841036053567: 91-2416
• 00841036053550: 91-2414
• 00841036053543: 91-2412
• 00841036053536: 91-2410
• 00841036053529: 91-2408
• 00841036053512: 91-2406
• 00888233012287: 95-2720