INTERMAXILLARY FIXATION SYSTEM SP-3017-05

GUDID 00841036168179

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: 00841036168179
• NIH Device Record Key: 522aa592-072e-4a3e-adf4-bf6084345278
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTERMAXILLARY FIXATION SYSTEM
• Version Model Number: SP-3017-05
• Catalog Number: SP-3017-05
• 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	00841036168179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983728

FDA Product Code

• DZL: SCREW, FIXATION, INTRAOSSEOUS

Sterilization

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

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

Moist Heat or Steam Sterilization

[00841036168179]

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 [INTERMAXILLARY FIXATION SYSTEM]

• 00841036168186: SP-3017-10
• 00841036168179: SP-3017-05
• 00841036163778: SP-3017
• 00841036056629: 95-5213
• 00841036053710: 91-5215
• 00841036053703: 91-5213
• 00888233021388: SP-3017-10
• 00888233021371: SP-3017-05
• 00888233021364: SP-3017