SureLOK Mini Posterior Cervical/Upper Thoracic System 04-SB-4032

GUDID 00840019907385

Ø4.0 x 32mm Bias Angle Smooth Shank Screw

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019907385
• NIH Device Record Key: 9ec571cf-05c9-4b02-af70-05b798376159
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLOK Mini Posterior Cervical/Upper Thoracic System
• Version Model Number: 04-SB-4032
• Catalog Number: 04-SB-4032
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Lot Batch: false
• 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	00840019907385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150851

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

[00840019907385]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-18
• Device Publish Date: 2019-04-10

On-Brand Devices [SureLOK Mini Posterior Cervical/Upper Thoracic System]

• 00840019920759: SureLOK™ PC System Implant Case (Empty)
• 00840019920742: SureLOK™ PC Instrument Case (Empty)
• 00840019920728: Ø3.5mm Smooth Shank Screw Caddy - Empty
• 00840019920704: 14mm, 4.0mm Drill
• 00840019920698: 14mm, 3.5mm Drill
• 00840019920681: Drill Shaft 4.0mm
• 00840019920674: 3.5mm Tap Sleeve
• 00840019920667: 4.0mm Tap
• 00840019920650: Cap Screw Inserter, small fixed handle
• 00840019920643: Cross-Link Anti-Torque Shaft
• 00840019920636: Anti-Torque Wrench
• 00840019920629: Handheld Ratcheting Rod Cutter
• 00840019920605: Ball Tip Probe Curved
• 00840019920599: Hook Inserter Tool
• 00840019920582: 6mm Hook Trial
• 00840019920575: 5mm Hook Trial
• 00840019920568: Distractor (3.5mm Rod)
• 00840019920544: Rod Template 3.25mm x 150mm
• 00840019920520: Rod Bender 3.5mm
• 00840019920513: LXH-04-0001
• 00840019920490: Cap Screw Inserter, double ended
• 00840019920483: Cross-Link Female Hex Shaft
• 00840019920476: 14mm Light Weight Drill Guide
• 00840019920469: Rod Pursuader (Small)
• 00840019920452: Screw Head Positioner Mini
• 00840019920445: Depth Gauge 50 mm
• 00840019920438: 3.5mm Rod Pusher
• 00840019920421: 4.0mm Tap Sleeve
• 00840019920391: Cervical Cross Link Inserter
• 00840019920384: Bone Awl
• 00840019920360: Polyaxial Screwdriver Mini
• 00840019920353: Tapered Hex Screwdriver 2.5mm
• 00840019920339: Drill Guide Adjustable
• 00840019920735: Ø4.0mm Smooth Shank Screw Caddy - Empty
• 00840019920711: Smooth Shank Screw Sterilization Case - Empty
• 00840019920612: Reducer, Kerrison Style
• 00840019920551: Compressor (3.5mm Rod)
• 00840019920537: Rod Holder 3.5mm
• 00840019920506: T-15 Hexalobe Torque Driver
• 00840019920414: Torque Limiting Handle
• 00840019920407: Drill Shaft 3.5mm
• 00840019920377: Torque Limiting Axial Handle
• 00840019920346: 3.5mm Tap
• 00815362022344: Universal Straight Handle Spinner Top
• 00840019907347: Ø4.0 x 24mm Bias Angle Smooth Shank Screw
• 00840019907330: Ø4.0 x 22mm Bias Angle Smooth Shank Screw
• 00840019907323: Ø4.0 x 20mm Bias Angle Smooth Shank Screw
• 00840019907316: Ø3.5 x 40mm Bias Angle Smooth Shank Screw
• 00840019907309: Ø3.5 x 38mm Bias Angle Smooth Shank Screw
• 00840019907293: Ø3.5 x 36mm Bias Angle Smooth Shank Screw