Simpact Tri-Fin 2017-0190

GUDID 00190837063221

Steinmann Pin, 300mm x 2.4mm Trocar-Blunt, CoCr

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837063221
NIH Device Record Key59f95e9f-fd12-417e-ab3b-69f0974049b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpact Tri-Fin
Version Model Number2017-0190
Catalog Number2017-0190
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
GS100190837063221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac joint fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

Moist Heat or Steam Sterilization

[00190837063221]

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 [Simpact Tri-Fin]

00190837020743152-12-970
00190837020736152-12-965
00190837020729152-12-960
00190837020712152-12-955
00190837020705152-12-950
00190837020699152-12-945
00190837020682152-12-940
00190837020675152-12-935
00190837020668152-12-930
00190837063337Anterior Curette #1 Ang 9" Handle
00190837063320Mallet 40mm Head 1lb 9oz - 9 1/2 Long
00190837063313Initial Dilation Tube w/ Threads
0019083706330614mm Parallel Pin Offset Guide
00190837063290Sleeve Drill, Short
00190837063283Parallel Pin Offset Guide, Large Screw
00190837063276Pin Holder, Long
00190837063269300mm x 2.4mm Steinmann Pin, Trocar-Flat, 17-4 SS
00190837063252530mm x 2.4mm Steinmann Pin, Flat-Flat, 17-4 SS
00190837063245300mm x 2.4 Steinmann Pin, Threaded-Blunt, CoCr
00190837063238Pin Caddy, 300mm x 2.4mm, CoCr Pins
00190837063221Steinmann Pin, 300mm x 2.4mm Trocar-Blunt, CoCr
00190837063214Steinmann Pin, Threaded-Blunt Ends
00190837063207#3 Dilation Tube, with handle
00190837063191Locking Screw Driver
00190837063184Locking Screw Driver
00190837063177SImpact Tri-Fin Screw Driver Button
00190837063160SImpact Tri-Fin Screw Driver
00190837063153Sleeve Drill
001908370631468.0mm Drill, Cannulated
00190837063139Final Dilation Tube
00190837063122Parallel Pin Offset Guide, Large Screw
00190837063115PARALLEL PIN OFFSET GUIDE, SMALL SCREW
00190837063108Triangular Pin Offset Guide, Large Screw
00190837063092Final Dilation Tube
00190837063085Depth Gage
00190837063078530mm x 2.4mm Steinmann Pin, Trocar-Blunt, 17-4 SS
00190837063061300mm x 2.4mm Steinmann Pin, Blunt-Blunt, 17-4 SS
00190837063054530mm x 2.4mm Steinmann Pin, Blunt-Blunt 17-4 SS
00190837063047530mm x 2.4mm Steinmann Pin, Threaded-Blunt 17-4 SS
00190837063030Parallel Pin Offset Guide, Large Screw
00190837063023Parallel Pin Offset Guide, Small Screw
00190837063016Pin Holder
00190837063009Large Mallet
00190837062996Steinmann Pin Caddy, Long Blunt Pins
00190837062989Steinmann Pin Caddy, Short Blunt Pins
00190837062972Steinmann Pin Caddy, Long Trocar Pins
00190837062965Steinmann Pin Caddy, Short Trocar Pins
00190837062958Implant Remover
001908370629411/4 Square Screw Driver, T30 Hexalobe
00190837062934SI Screw Driver Sleeve
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.