POLARIS 5.5 SPINAL SYSTEM 2000-2325

GUDID 00888480207542

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 ID00888480207542
NIH Device Record Key35983f61-cc58-4621-bb7c-f5ef14805bfe
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOLARIS 5.5 SPINAL SYSTEM
Version Model Number2000-2325
Catalog Number2000-2325
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

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
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Device Identifiers

Device Issuing AgencyDevice ID
GS100888480207542 [Primary]

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


[00888480207542]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-03-10
Device Publish Date2015-10-24

On-Brand Devices [POLARIS 5.5 SPINAL SYSTEM]

0088030481892720005541R
0088030481891020005541L
0088030481890320005539R
0088030481889720005539L
0088030481888020005537R
008803048188732000-5537L
008884802075352000-2320
008884802075282000-2299
008884802075112000-2295
008884802075042000-2290
008884802074982000-2285
008884802074812000-2280
008884802074742000-2275
008884802074672000-2270
008884802074502000-2265
008884802074432000-2260
008884802074362000-2255
008884802074292000-2250
008884802074122000-2245
008884802074052000-2240
008884802073992000-2235
008884802073822000-2230
008884802073752000-2225
008884802073682000-2220
008884802073512000-2199
008884802073372000-2190
008884802073202000-2185
008884802073132000-2180
008884802073062000-2175
008884802072902000-2170
008884802072832000-2165
008884802072762000-2160
008884802072692000-2155
008884802072522000-2150
008884802072452000-2145
008884802072382000-2140
008884802072212000-2135
008884802072142000-2130
008884802072072000-2125
008884802071912000-2120
0088848017473814-512499
0088848017472114-512495R
0088848017471414-512495
0088848017470714-512490R
0088848017469114-512490
0088848017468414-512485R
0088848017467714-512485
0088848017466014-512480R
0088848017465314-512480
0088848017464614-512475R

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