Polaris™ 6.35/Synergy™ 6757

GUDID 00888480405092

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 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 Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00888480405092
NIH Device Record Keya28d9a84-6af2-48b7-bbaa-e5b3d99b568c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolaris™ 6.35/Synergy™
Version Model Number6757
Catalog Number6757
Company DUNS018577570
Company NameBIOMET SPINE LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com
Phone+1(800)447-3625
EmailUSBROCustomerService@zimmerbiomet.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100888480405092 [Primary]

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


[00888480405092]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

On-Brand Devices [Polaris™ 6.35/Synergy™]

008884804050926757
008884804050786756
008884804050546755

Trademark Results [Polaris]

Mark Image

Registration | Serial
Company
Trademark
Application Date
POLARIS
POLARIS
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2024-03-19
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POLARIS
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2023-12-15
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2023-10-26
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2023-09-15
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POLARIS
98137930 not registered Live/Pending
Aristocrat Technologies, Inc.
2023-08-17
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POLARIS
98019926 not registered Live/Pending
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2023-05-30
POLARIS
POLARIS
97900337 not registered Live/Pending
Horizon Surgical Systems, Inc.
2023-04-21
POLARIS
POLARIS
97835888 not registered Live/Pending
JetBrains s.r.o
2023-03-13
POLARIS
POLARIS
97733981 not registered Live/Pending
Galaxy Group Inc.
2022-12-28
POLARIS
POLARIS
97661590 not registered Live/Pending
Polaris Industries Inc.
2022-11-03

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