Polaris™ 6.35/Synergy™ 6755

GUDID 00888480405054

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
Primary Device ID00888480405054
NIH Device Record Keyf88ba642-ee6b-4864-b710-358ac70eb6e6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePolaris™ 6.35/Synergy™
Version Model Number6755
Catalog Number6755
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
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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
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]
GS100888480405054 [Primary]

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

Moist Heat or Steam Sterilization


[00888480405054]

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

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