Solstice Occipito-Cervico-Thoracic System 904-2427

GUDID 00190837063474

24mm-27mm SOLSTICE Cross Connector, Straight

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837063474
NIH Device Record Key5c53cefd-dcad-49d8-857c-7ff4a6190ea9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolstice Occipito-Cervico-Thoracic System
Version Model Number904-2427
Catalog Number904-2427
Company DUNS183641617
Company NameLife Spine, Inc.
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837063474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


[00190837063474]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Solstice Occipito-Cervico-Thoracic System]

001908370215669335-26
00190837021559900-003
001908370215429200-11
001908370172559245-50
001908370172489245-45
001908370172319245-40
001908370172249245-35
001908370172179245-30
001908370172009245-28
001908370171949245-26
001908370171879245-25
001908370171709245-24
001908370171639245-22
001908370171569245-20
001908370171499245-18
001908370171329245-16
001908370171259245-14
001908370171189245-12
001908370171019245-10
001908370170959240-50
001908370170889240-45
001908370170719240-40
001908370170649240-35
001908370170579240-30
001908370170409240-28
001908370170339240-26
001908370170269240-25
001908370170199240-24
001908370170029240-22
001908370169999240-20
001908370169829240-18
001908370169759240-16
001908370169689240-14
001908370169519240-12
001908370169449240-10
001908370169379235-50
001908370169209235-45
001908370169139235-40
001908370169069235-35
001908370168909235-30
001908370168839235-28
001908370168769235-26
001908370168699235-25
001908370168529235-24
001908370168459235-22
001908370168389235-20
001908370168219235-18
001908370168149235-16
001908370168079235-14
001908370167919235-12

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