External Fixation 172-00-160

GUDID 00190837033194

Life Spine, Inc.

External orthopaedic fixation system, single-use, non-sterile
Primary Device ID00190837033194
NIH Device Record Keya456c24b-f193-4433-bf3c-8f505960dbe6
Commercial Distribution StatusIn Commercial Distribution
Brand NameExternal Fixation
Version Model Number172-00-160
Catalog Number172-00-160
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
GS100190837033194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

Moist Heat or Steam Sterilization


[00190837033194]

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 [External Fixation]

00190837034115Foot Plate, 220mm
00190837034016Hex Driver, A/O
00190837033972Short Drill Sleeve
00190837033965Drill Sleeve
001908370339584.8mm Short Drill
001908370339413.8mm Short Drill
001908370339342.7mm Short Drill
00190837023720Oblique Support
00190837023713Outboard Hinge
00190837023706Inline Hinge
00190837023690Universal Hinge
00190837023683Walker Rail
00190837023676Distraction Nut
00190837023614Foot Plate, 200mm
00190837023577Foot Plate, 120mm
00190837023560Foot Plate, 100mm
00190837023331Full Ring, 120mm
00190837023317Large Strut
00190837023300Medium Strut
00190837023294Small Strut
00190837023287200mm Threaded Rod
00190837023270165mm Threaded Rod
00190837023263115mm Threaded Rod
0019083702325685 Threaded Rod
0019083702324960mm Threaded Rod
00190837023232Rancho Cube, 5 Hole
00190837023225Rancho Cube, 4 Hole
00190837023218Rancho Cube, 3 Hole
00190837023201Rancho Cube, 2 Hole
00190837023195Rancho Cube, 1 Hole
00190837023188Straight Plate, 4 Hole
00190837023171Straight Plate, 3 Hole
00190837023164Straight Plate, 2 Hole
00190837023157Straight Plate, 1 Hole
00190837023140Female Post, 5 Hole
00190837023133Female Post, 4 Hole
00190837023126Female Post, 3 Hole
00190837023119Female Post, 2 Hole
00190837023102Female Post, 1 Hole
00190837023096Male Post, 5 Hole
00190837023089Male Post, 4 Hole
00190837023072Male Post, 3 Hole
00190837023065Male Post, 2 Hole
00190837023058Male Post, 1 Hole
0019083702304116mm Extension Nut
001908370230348mm Extension Nut
00190837023027Slotted Washer
00190837023010Washer
00190837023003Nut
0019083702299030mm Bolt

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