Solstice Core System 117-757

GUDID 00190837104528

Cervical Adjustable Drill Guide

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837104528
NIH Device Record Key11b4a300-9d2c-4b3d-b82b-d96d63a40ac1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolstice Core System
Version Model Number117-757
Catalog Number117-757
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 Usefalse
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
GS100190837104528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837104528]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

On-Brand Devices [Solstice Core System]

001908371045423.5mm Rod Template
00190837104535Cervical Adjustable Depth Gauge
00190837104528Cervical Adjustable Drill Guide
00190837104511Empty Sterilization Tray

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