Polaris™ 6.35 Spinal System 14-513730R

GUDID 00880304964143

BIOMET SPINE LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00880304964143
• NIH Device Record Key: c7a593f9-6029-409d-80a3-56d4f778dd51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polaris™ 6.35 Spinal System
• Version Model Number: 14-513730R
• Catalog Number: 14-513730R
• Company DUNS: 018577570
• Company Name: BIOMET SPINE LLC
• 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(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com
• Phone: +1(800)447-3625
• Email: USBROCustomerService@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304964143 [Primary]

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

[00880304964143]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-03-10
• Device Publish Date: 2020-11-10

On-Brand Devices [Polaris™ 6.35 Spinal System]

• 00880304877481: 14-501009
• 00880304877474: 14-501008
• 00880304877467: 14-501007
• 00880304877450: 14-501006
• 00880304877443: 14-501005
• 00880304877436: 14-501004
• 00880304877429: 14-501003
• 00880304973251: 14-501040
• 00880304973244: 14-501041
• 00880304973237: 14-501042
• 00880304973220: 14-501043
• 00880304973213: 14-501044
• 00880304973206: 14-501045
• 00880304973190: 14-501046
• 00880304973183: 14-501047
• 00880304973176: 14-501048
• 00880304973169: 14-501049
• 00880304973152: 14-501050
• 00880304973145: 14-501051
• 00880304973138: 14-501052
• 00880304973121: 14-501053
• 00880304973114: 14-501054
• 00880304973107: 14-501055
• 00880304973091: 14-501056
• 00880304973084: 14-501057
• 00880304973077: 14-501058
• 00880304973060: 14-501059
• 00880304973053: 14-501060
• 00880304973046: 14-501061
• 00880304973039: 14-501062
• 00880304973022: 14-501063
• 00880304973015: 14-501064
• 00880304973008: 14-501065
• 00880304972995: 14-501289
• 00880304972988: 14-501291
• 00880304972971: 14-501293
• 00880304972964: 14-501295
• 00880304972957: 14-501297
• 00880304972940: 14-501298
• 00880304965157: 14-513120R
• 00880304965140: 14-513130R
• 00880304965133: 14-513135R
• 00880304965126: 14-513140R
• 00880304965119: 14-513145R
• 00880304965102: 14-513150R
• 00880304965096: 14-513155R
• 00880304965089: 14-513160R
• 00880304965072: 14-513165R
• 00880304965065: 14-513175R
• 00880304965058: 14-513180R