SOLSTICE Instruments 2019-0062

GUDID 00190837077402

Posterior Cervical Fixation Pin, Ø2mm

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837077402
NIH Device Record Key3517057f-de88-4ad2-8104-f391bfd3bc19
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLSTICE Instruments
Version Model Number2019-0062
Catalog Number2019-0062
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
GS100190837077402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837077402]

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 Instruments]

00190837077433Posterior Cervical Access Tube
00190837077426Dilation Tube
00190837077419Guide Pin, Trocar, 3.0mm
00190837077402Posterior Cervical Fixation Pin, Ø2mm

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