Polaris™ 6.35/Synergy™ 6756

GUDID 00888480405078

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 ID00888480405078
NIH Device Record Key62e2b7af-b29d-4799-bb01-9e665c5c4fce
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolaris™ 6.35/Synergy™
Version Model Number6756
Catalog Number6756
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100888480405078 [Primary]

FDA Product Code

KWQAppliance, fixation, spinal intervertebral body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

Moist Heat or Steam Sterilization


[00888480405078]

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
98457168 not registered Live/Pending
Tidal Flight, Inc.
2024-03-19
POLARIS
POLARIS
98432314 not registered Live/Pending
Nzytech, Lda
2024-03-04
POLARIS
POLARIS
98317305 not registered Live/Pending
Sky Bacon Technology Holdings, LLC
2023-12-15
POLARIS
POLARIS
98242561 not registered Live/Pending
Ballbaron.com LLC
2023-10-26
POLARIS
POLARIS
98232012 not registered Live/Pending
CEREVASC, INC.
2023-10-19
POLARIS
POLARIS
98182468 not registered Live/Pending
Airtron, Inc.
2023-09-15
POLARIS
POLARIS
98137930 not registered Live/Pending
Aristocrat Technologies, Inc.
2023-08-17
POLARIS
POLARIS
98019926 not registered Live/Pending
Polaris Teen Center, LLC
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.