N/A SP-1818

GUDID 00841036282530

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 00841036282530
• NIH Device Record Key: b5fd2a7a-5ea6-4ea7-b1fb-8b2bb8cdd857
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: SP-1818
• Catalog Number: SP-1818
• 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
• 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
• 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
• 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	00841036282530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

[00841036282530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

On-Brand Devices [N/A]

• 00841036048402: 51-1610
• 00841036048396: 51-1600
• 00841036027988: 09-0229
• 00841036027926: 09-0222
• 00841036027919: 09-0221
• 00841036027889: 09-0217
• 00841036027865: 09-0215
• 00841036027858: 09-0214
• 00841036027834: 09-0212
• 00841036027735: 09-0201
• 00841036208974: 02-0424
• 00841036159696: 02-8426
• 00841036148768: 33-0124
• 00841036130596: 02-8432
• 00841036128340: 12-0010
• 00841036127831: 02-8428
• 00841036086022: 12-0013
• 00841036043063: 33-0125
• 00841036043025: 33-0120
• 00841036042912: 33-0090
• 00841036042776: 33-0054
• 00841036041489: 28-0620
• 00841036031534: 12-0247
• 00841036031527: 12-0245
• 00841036031510: 12-0242
• 00841036031398: 12-0083
• 00841036031206: 12-0050
• 00841036031190: 12-0047
• 00841036031183: 12-0045
• 00841036031176: 12-0042
• 00841036031169: 12-0041
• 00841036031114: 12-0036
• 00841036031107: 12-0035
• 00841036030957: 12-0007
• 00841036030940: 12-0006
• 00841036030933: 12-0005
• 00841036030926: 12-0004
• 00841036030919: 12-0003
• 00841036030902: 12-0002
• 00841036030896: 12-0001
• 00841036024284: 03-1218
• 00841036024260: 03-1210
• 00841036024253: 03-1205
• 00841036024246: 03-1200
• 00841036023157: 02-9128
• 00841036023133: 02-9122
• 00841036021733: 02-5290
• 00841036007140: 01-0263
• 00841036135096: SP-2298
• 00841036023607: 03-0073