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 ID: 00190837082000
• NIH Device Record Key: 3b6b38d1-e5ff-472a-9792-b774a6685fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nautilus
• Version Model Number: 112-281
• Catalog Number: 112-281
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837082000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111953

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00190837082000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [Nautilus]

• 00190837033286: Nautilus Instrument
• 00190837089436: Nautilus T25 Polyaxial Screw Driver, Cannulated, Reduction
• 00190837089429: Nautilus T25 Polyaxial Screw Driver, Non-Cannulated
• 00190837089375: Nautilus T20 Polyaxial Screw Driver, Non-Cannulated, Reduction
• 00190837089368: Nautilus T20 Polyaxial Screw Driver, Non-Cannulated
• 00190837086718: Hexalobe T-25 Screwdriver, Cannulated, Short
• 00190837076122: SMALL MECHANICAL COMPRESSOR
• 00190837075859: ROD REDUCTION/DEROTATION TUBE
• 00190837075842: Rod Reduction Tube Triangle Drive Key, Body
• 00190837075835: 1/4 Square Rod Reduction Driver
• 00190837075828: Modular Compressor
• 00190837075811: DISTRACTOR MODULAR TIPS
• 00190837091057: Depth Gauge Housing
• 00190837091040: Depth Guage
• 00190837090883: 1/4" Square Long Handle
• 00190837089443: Nautilus T25 Polyaxial Screw Driver, Non-Cannulated, Reduction
• 00190837089412: Nautilus T25 Polyaxial Screw Driver, Cannulated
• 00190837089405: Nautilus T25 Polyaxial Screw Driver, Non-Cannulated, Reduction
• 00190837089399: Nautilus T25 Polyaxial Screw Driver, Cannulated, Reduction
• 00190837089382: Nautilus T25 Polyaxial Screw Driver, Non-Cannulated
• 00190837086725: Hexalobe T-25 Screwdriver, Non-Cannulated, Short
• 00190837085599: 5.5 Static Rod Rocker, Bayonetted
• 00190837079253: 5.5mm Static Rod Rocker, Bayonetted
• 00190837076023: 8.5mm Tap, Cannulated
• 00190837076016: 1/4 Square Torque Limiting T-Handle, 80 in-lbs
• 00190837076009: 1/4 Square Deflection Beam T-Handle, 80 in-lbs
• 00190837075996: 5.5mm Kerrison Rod Reducer
• 00190837075989: LENKE STYLE STRAIGHT PROBE
• 00190837075972: OVER ROD RADIAL DISTRACTOR
• 00190837075965: CURVED PROBE, STANDARD
• 00190837075958: Straight Probe
• 00190837075941: Curved Probe, Aggressive
• 00190837075934: Modular Lumbar Tapered Probe
• 00190837075927: 5.5MM ROD BENDER
• 00190837075910: Thoracic Probe
• 00190837075903: Sacral Probe
• 00190837075897: Lumbar Flat Probe
• 00190837075880: Small Compressor
• 00190837075873: 5.5mm Rod Gripper
• 00190837075866: 5.5mm Rod Pusher
• 00190837075804: Lumbar Rod Persuader
• 00190837075798: 1/4 SQUARE PEDICLE MARKER
• 00190837075781: 5.5MM HEAD MANIPULATOR
• 00190837075774: 5.5MM ROD BENDER
• 00190837075767: AROUND THE SCREW TIP
• 00190837075750: AROUND THE SCREW TIP
• 00190837075743: DISTAL TIP
• 00190837075736: DISTAL TIP
• 00190837075729: FORCEP ROD ROCKER
• 00190837075712: 1/4 Square Pedicle Marker, Notched