AVATAR Minimally Invasive Spinal System Instruments 116-847

GUDID 00190837033033

Percutaneous Rod Inserter, 15 degree

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00190837033033
• NIH Device Record Key: 7b02b867-c665-4285-8f56-460d7ac21107
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVATAR Minimally Invasive Spinal System Instruments
• Version Model Number: 116-847
• Catalog Number: 116-847
• 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	00190837033033 [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

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

[00190837033033]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [AVATAR Minimally Invasive Spinal System Instruments]

• 00190837033064: #3 Dilation Tube, Stainless Steel
• 00190837033040: #1 Dilation Tube, Stainless Steel
• 00190837032821: Hexalobe T20 Screwdriver, Cannulated
• 00190837032784: DILATION TUBE 4
• 00190837033088: CT / Tower Breaker
• 00190837033071: 1/4 Square Torque Limiting T-Handle, 80 in-lbs
• 00190837033057: #2 Dilation Tube, Stainless Steel
• 00190837033033: Percutaneous Rod Inserter, 15 degree
• 00190837033026: Bulleted Rod Inserter, Static
• 00190837033019: Polyaxial Screwdriver
• 00190837033002: One Step Dilator, 4
• 00190837032999: One Step Dilator, 3
• 00190837032982: 21" X 1.27mm K-Wire, Blunt-Blunt, Nitinol
• 00190837032975: 21" X 1.17mm K-wire, Blunt-Blunt, Nitinol
• 00190837032968: 21" x 1.4mm K-wire, Blunt-Trocar, Nitinol
• 00190837032951: 21" x 1.4mm K-wire, Blunt-Blunt, Stainless Steel
• 00190837032944: 21" x 1.4mm K-wire, Blunt-Trocar, Stainless Steel
• 00190837032937: Jamshidi Needle
• 00190837032920: MIS CALIPER
• 00190837032913: MIS COMPRESSOR-DISTRACTOR DRIVER
• 00190837032906: MIS COMPRESSOR ADJUSTABLE FULCRUM
• 00190837032890: MIS Compressor - Distractor
• 00190837032883: Blunt Dissector
• 00190837032876: CT/TOWER BREAKER
• 00190837032869: LARGE 1/4" SQ RATCHET HANDLE
• 00190837032852: Avatar 2.0 Instrument Tray 2 Top Level
• 00190837032845: Avatar 2.0 Instrument Tray 2
• 00190837032838: Avatar Extended Tab MIS System - Instrument Tray 2
• 00190837032814: 1/4 Square Torque Limiting T-Handle, 80 in-lbs
• 00190837032807: 5.5mm Rod/Cross Connector Holder
• 00190837032791: DILATION TUBE 5
• 00190837032777: Detachable Counter Torque Handle
• 00190837032760: PERCUTANEOUS ROD INSERTER
• 00190837032753: MIS POLYAXIAL SCREW DRIVER
• 00190837032746: Initial Cap Tightener
• 00190837032739: Locking Cap Driver
• 00190837032722: Reduction Driver
• 00190837032715: 21" x 1.4mm K-wire, Blunt-Blunt, Nitinol
• 00190837032708: Detachable Counter Torque Wrench
• 00190837032692: MIS TAP, 7.5MM
• 00190837032685: MIS TAP, 6.5MM
• 00190837032678: MIS TAP, 5.5MM
• 00190837032661: MIS TAP, 4.5MM
• 00190837032654: MIS INITIAL DILATION TUBE
• 00190837032647: 1/4" SQ RATCHET T-HANDLE
• 00190837032630: K-wire Caddy
• 00190837032623: Avatar 2.0 Instrument Tray 1
• 00190837032616: Avatar Entended Tab MIS System - Instrument Tray 1
• 00190837032609: 4.5mm MIS Screw Caddy
• 00190837032593: Locking Cap Caddy