Nautilus 112-281

GUDID 00190837082000

Torque Limit Large 1/4 Inch Sq Handle, 80in-lb

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837082000
NIH Device Record Key3b6b38d1-e5ff-472a-9792-b774a6685fbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus
Version Model Number112-281
Catalog Number112-281
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
GS100190837082000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837082000]

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 [Nautilus]

00190837033286Nautilus Instrument
00190837089436Nautilus T25 Polyaxial Screw Driver, Cannulated, Reduction
00190837089429Nautilus T25 Polyaxial Screw Driver, Non-Cannulated
00190837089375Nautilus T20 Polyaxial Screw Driver, Non-Cannulated, Reduction
00190837089368Nautilus T20 Polyaxial Screw Driver, Non-Cannulated
00190837086718Hexalobe T-25 Screwdriver, Cannulated, Short
00190837076122SMALL MECHANICAL COMPRESSOR
00190837075859ROD REDUCTION/DEROTATION TUBE
00190837075842Rod Reduction Tube Triangle Drive Key, Body
001908370758351/4 Square Rod Reduction Driver
00190837075828Modular Compressor
00190837075811DISTRACTOR MODULAR TIPS
00190837091057Depth Gauge Housing
00190837091040Depth Guage
001908370908831/4" Square Long Handle
00190837089443Nautilus T25 Polyaxial Screw Driver, Non-Cannulated, Reduction
00190837089412Nautilus T25 Polyaxial Screw Driver, Cannulated
00190837089405Nautilus T25 Polyaxial Screw Driver, Non-Cannulated, Reduction
00190837089399Nautilus T25 Polyaxial Screw Driver, Cannulated, Reduction
00190837089382Nautilus T25 Polyaxial Screw Driver, Non-Cannulated
00190837086725Hexalobe T-25 Screwdriver, Non-Cannulated, Short
001908370855995.5 Static Rod Rocker, Bayonetted
001908370792535.5mm Static Rod Rocker, Bayonetted
001908370760238.5mm Tap, Cannulated
001908370760161/4 Square Torque Limiting T-Handle, 80 in-lbs
001908370760091/4 Square Deflection Beam T-Handle, 80 in-lbs
001908370759965.5mm Kerrison Rod Reducer
00190837075989LENKE STYLE STRAIGHT PROBE
00190837075972OVER ROD RADIAL DISTRACTOR
00190837075965CURVED PROBE, STANDARD
00190837075958Straight Probe
00190837075941Curved Probe, Aggressive
00190837075934Modular Lumbar Tapered Probe
001908370759275.5MM ROD BENDER
00190837075910Thoracic Probe
00190837075903Sacral Probe
00190837075897Lumbar Flat Probe
00190837075880Small Compressor
001908370758735.5mm Rod Gripper
001908370758665.5mm Rod Pusher
00190837075804Lumbar Rod Persuader
001908370757981/4 SQUARE PEDICLE MARKER
001908370757815.5MM HEAD MANIPULATOR
001908370757745.5MM ROD BENDER
00190837075767AROUND THE SCREW TIP
00190837075750AROUND THE SCREW TIP
00190837075743DISTAL TIP
00190837075736DISTAL TIP
00190837075729FORCEP ROD ROCKER
001908370757121/4 Square Pedicle Marker, Notched

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