Simpact 152-08-645

GUDID 00190837101541

SI Screw, Lag, 8mm x 45mm

Life Spine, Inc.

Interspinous spinal fixation implant
Primary Device ID00190837101541
NIH Device Record Key5c0f22e6-09d2-4de4-8ae3-23345d429bf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimpact
Version Model Number152-08-645
Catalog Number152-08-645
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
GS100190837101541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac joint fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837101541]

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 [Simpact]

001908370953698.0mm Drill, Cannulated, Short
00190837089245Pin Holder
001908370892388.0mm Drill, Cannulated
00190837089221300mm x 2.4mm Steinmann Pin, Trocar-Blunt, CoCr
00190837089214300mm x 2.4mm Steinmann Pin, Threaded-Blunt, CoCr
00190837089191300mm x 2.4mm Steinmann Pin, Threaded-Blunt, 17.4 SS
00190837089184SImpact 12mm Screw Caddy
00190837083946154-170
0019083707966690 degree Cup Curette, Right #2, 10mm Tip
0019083707965990 degree Cup Curette, Left #2, 10mm Tip
00190837079642530mm x 2.4mm Steinmann Pin, Blunt-Blunt, Stainless Steel
00190837079635Cannula Cleaner, Stainless Steel
00190837079222Locking Screw Driver
00190837075590Triangular Pin Offset Guide, 16-16-18
0019083707558316mm Triangular Pin Offset Guide
0019083707557616mm Parallel Pin Offset Guide
001908370755698.0mm Drill, Cannulated
0019083707555214mm Parallel Pin Offset Guide
00190837071318SImpact Instrument Tray, Lid
00190837071301Simpact Implant Tray, Base
00190837071295SImpact Implant Tray, Lower Tray
00190837071288SImpact Implant Tray, Lid
00190837071271SImpact System- Instrument Tray
00190837071264SImpactSystem- Implant Tray
00190837071257LARGE QUICK CONNECT HANDLE
00190837101572SI Screw, Lag, 8mm x 60mm
00190837101565SI Screw, Lag, 8mm x 55mm
00190837101558SI Screw, Lag, 8mm x 50mm
00190837101541SI Screw, Lag, 8mm x 45mm
00190837101534SI Screw, Lag, 8mm x 40mm
00190837101527SI Screw, Lag, 8mm x 35mm

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