2.0 SYSTEM SP-1737

GUDID 00841036174439

BIOMET MICROFIXATION, INC

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 00841036174439
• NIH Device Record Key: 954e86e0-1e73-4b6a-b008-32eafc4d3580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0 SYSTEM
• Version Model Number: SP-1737
• Catalog Number: SP-1737
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036174439 [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

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

Moist Heat or Steam Sterilization

[00841036174439]

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 [2.0 SYSTEM]

• 00841036282851: SP-2207
• 00841036282844: SP-2206
• 00841036282837: SP-2205
• 00841036282820: SP-2204
• 00841036282813: SP-2203
• 00841036282806: SP-2202
• 00841036282790: SP-2200
• 00841036282394: SP-1738
• 00841036282387: SP-1737
• 00841036282370: SP-1736
• 00841036282363: SP-1735
• 00841036282271: SP-1704
• 00841036282264: SP-1703
• 00841036282257: SP-1702
• 00841036282875: SP-2209L
• 00841036282868: SP-2208
• 00841036232290: SP-3348
• 00841036232283: SP-3346
• 00841036231323: SP-3347
• 00841036231187: SP-3345
• 00841036209964: SP-3290
• 00841036209957: SP-3289
• 00841036209940: SP-3288
• 00841036209933: SP-3287
• 00841036209926: SP-3286
• 00841036209919: SP-3285
• 00841036209902: SP-3284
• 00841036209896: SP-3282
• 00841036209889: SP-3281
• 00841036209872: SP-3279
• 00841036209865: SP-3278
• 00841036209858: SP-3275
• 00841036209841: SP-3274
• 00841036209834: SP-3273
• 00841036209827: SP-3272
• 00841036209810: SP-3271
• 00841036209803: SP-3270
• 00841036209797: SP-3269
• 00841036209780: SP-3267
• 00841036209773: SP-3266
• 00841036209766: SP-3264
• 00841036209759: SP-3263
• 00841036208097: SP-3291
• 00841036208080: SP-3283
• 00841036208073: SP-3280
• 00841036208066: SP-3277
• 00841036208059: SP-3276
• 00841036208042: SP-3268
• 00841036208035: SP-3265
• 00841036208028: SP-3262