Simpact Sacroiliac Joint Compression Screw System

GUDID 00190837014094

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837014094
NIH Device Record Keyec85a830-8df9-4070-944f-9473aa09e03d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpact Sacroiliac Joint Compression Screw System
Version Model Number152-08-145
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exempttrue
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
GS100190837014094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837014094]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-20

On-Brand Devices [Simpact Sacroiliac Joint Compression Screw System]

00190837014247152-12-770
00190837014230152-12-765
00190837014223152-12-760
00190837014216152-12-755
00190837014209152-12-750
00190837014193152-12-745
00190837014186152-12-740
00190837014179152-12-735
00190837014162152-12-730
00190837014155152-12-420
00190837014148152-12-415
00190837014131152-12-410
00190837014124152-08-160
00190837014117152-08-155
00190837014100152-08-150
00190837014094152-08-145
00190837014087152-08-140
00190837014070152-08-135

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