SureLOK Pedicle Screw System 21-1091-CA

GUDID 00815362023327

Instrument Kit

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00815362023327
• NIH Device Record Key: ae274b75-4ea4-4442-a085-e289d42d86f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureLOK Pedicle Screw System
• Version Model Number: 21-1091-CA
• Catalog Number: 21-1091-CA
• 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: false
• 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	00815362023327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092128

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00815362023327]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-09
• Device Publish Date: 2019-04-01

On-Brand Devices [SureLOK Pedicle Screw System ]

• 00815362023327: Instrument Kit
• 00815362023310: MIS Caliper Assembly
• 00815362023303: Tower
• 00815362022009: SureLOK MIS Tissue Cutter
• 00815362021996: SureLOK MIS Locking Cap Inserter
• 00815362021989: SureLOK MIS K-Wire Retractor
• 00815362021965: SureLOK MIS Tower Hinge
• 00815362021958: SureLOK MIS Rod Inserter, percutaneous
• 00815362021941: SureLOK MIS MIS Torque Driver
• 00815362021934: SureLOK MIS MIS Distractor
• 00815362021927: SureLOK MIS Compressor
• 00815362021910: SureLOK MIS Mallet
• 00815362021903: SureLOK MIS Cannulated Awl
• 00815362021897: SureLOK MIS ø8.5mm Cannulated Pedicle Screw Tap
• 00815362021873: SureLOK MIS ø7.5mm Cannulated Pedicle Screw Tap
• 00815362021866: SureLOK MIS ø6.5mm Cannulated Pedicle Screw Tap
• 00815362021859: SureLOK MIS ø5.5mm Cannulated Pedicle Screw Tap
• 00815362021835: SureLOK MIS Radel Dilation Tube 24mm
• 00815362021828: SureLOK MIS Radel Dilation Tube 18mm
• 00815362021804: SureLOK MIS Radel Dilation Tube 13mm
• 00815362021781: SureLOK MIS Radel Dilation Tube 8mm
• 00815362021743: SureLOK MIS Rod Reducer
• 00815362021736: SureLOK MIS K-Wire