2.4MM SYSTEM 85-2416

GUDID 00841036061791

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036061791
• NIH Device Record Key: bfe94d73-6173-410b-89fe-0b6a93fa76ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4MM SYSTEM
• Version Model Number: 85-2416
• Catalog Number: 85-2416
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036061791 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001238

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036061791]

Moist Heat or Steam Sterilization

[00841036061791]

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]

• 00841036088873: 2.7X18MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036083779: 85-2440
• 00841036083762: 85-2436
• 00841036083755: 85-2432
• 00841036083748: 85-2428
• 00841036083731: 85-2424
• 00841036083724: 85-2420
• 00841036072995: 85-2406
• 00841036071240: 81-2432
• 00841036071233: 81-2428
• 00841036071226: 81-2440
• 00841036070915: 81-2436
• 00841036070519: 81-2424
• 00841036070328: 2.7X14MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036066468: 81-2420
• 00841036065300: 2.7X16MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036063115: 24-9905
• 00841036061814: 81-2410
• 00841036061807: 85-2410
• 00841036061791: 85-2416
• 00841036061784: 81-2416
• 00841036061777: 85-2414
• 00841036061760: 81-2414
• 00841036061753: 85-2412
• 00841036061746: 81-2412
• 00841036061722: 2.7MM X 6MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061708: 81-2418
• 00841036061661: 2.7MM X 8MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061654: 2.7MM X 16MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061630: 2.7MM X 14MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061609: 2.7MM X 12MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061593: 2.7MM X 10MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061586: 2.7MM X 18MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036061579: 85-2418
• 00841036059651: 81-2406
• 00841036059613: 81-2408
• 00841036058944: 85-2408
• 00841036053659: 2.7X12MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036053642: 2.7X10MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036053635: 2.7X8MM HIGH TORQUE CROSS-DRIVE SCREW
• 00841036053628: 2.7X6MM HIGH TORQUE CROSS-DRIVE SCREW