THINFLAP SYSTEM 91-6903

GUDID 00888233001564

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00888233001564
• NIH Device Record Key: 72266549-e9ff-428c-af69-e38d26f610ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THINFLAP SYSTEM
• Version Model Number: 91-6903
• Catalog Number: 91-6903
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233001564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GXR: COVER, BURR HOLE

Sterilization

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

[00888233001564]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-18

On-Brand Devices [THINFLAP SYSTEM]

• 00841036219468: 91-6703-50
• 00841036219451: 91-6704-50
• 00841036191153: SP-3218
• 00841036169312: SP-3038
• 00841036151386: 91-6903
• 00841036151362: 95-6903
• 00841036141974: 91-6703
• 00841036141967: 95-6703
• 00841036134938: 91-6904
• 00841036134921: 95-6904
• 00841036134815: 95-6704
• 00841036134808: 91-6704
• 00841036129323: 19-1021
• 00841036123895: 91-6804-EA
• 00841036122935: 19-1019
• 00841036122904: 19-1020B
• 00841036122898: 91-6604-EA
• 00841036088507: 19-1075
• 00841036088491: 19-1070
• 00841036088484: 19-1065
• 00841036088477: 19-1060
• 00841036088460: 19-1055
• 00841036088453: 19-1050
• 00841036088446: 19-1045
• 00841036088439: 19-1040
• 00841036088422: 19-1035
• 00888233021555: SP-3038
• 00888233018135: SP-3218
• 00888233007221: 19-1021
• 00888233000239: 19-1020B
• 00888233000222: 19-1019
• 00888233025324: 91-6804-EA
• 00888233012300: 95-6903
• 00888233001649: 95-6904
• 00888233001632: 95-6704
• 00888233001625: 95-6703
• 00888233001571: 91-6904
• 00888233001564: 91-6903
• 00888233001557: 91-6704
• 00888233001540: 91-6703
• 00888233001533: 91-6604-EA