Navigated Instrument System 70-BK-0109

GUDID 00840019942935

Reform Ti CT Modular MIS Navigated Instrument Kit

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019942935
• NIH Device Record Key: e615dfa9-2bc2-4222-8dfb-3a8d1ca3c01d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigated Instrument System
• Version Model Number: 70-BK-0109
• Catalog Number: 70-BK-0109
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00840019942935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181606

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

[00840019942935]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [Navigated Instrument System]

• 00840019939324: SureLOK MIS 3L Navigated Instrument Kit
• 00840019939317: Reform MC and MC Hybrid Navigated Instrument Kit
• 00840019939300: Cannulated Reform Ti Modular Navigated Instrument Kit
• 00840019939294: Non-Cannulated Reform Ti Modular Navigated Instrument Kit
• 00840019939287: Cannulated Reform Ti Navigated Instrument Kit
• 00840019939270: Non-Cannulated Reform Ti Navigated Instrument Kit
• 00840019939263: Reform HA Navigated Instrument Kit
• 00840019939256: Reform Modular Navigated Instrument Kit
• 00840019939249: Reform Navigated Instrument Kit
• 00840019942775: Reform Ti CT Cannulated T25 Poly Driver, Stealth Navigation
• 00840019942935: Reform Ti CT Modular MIS Navigated Instrument Kit
• 00840019938914: Reform MC Modular Driver, Cannulated, Navigated
• 00840019938907: Reform MC Modular Driver, Non-Cannulated, Navigated
• 00840019938891: Reform MC Polyaxial Driver, Non-Cannulated, Navigated
• 00840019938884: Reform MC Tap (9.5mm Screw), Non-Cannulated, Navigated
• 00840019938877: Reform MC Tap (8.5mm Screw), Non-Cannulated, Navigated
• 00840019938860: Reform MC Tap (7.5mm Screw), Non-Cannulated, Navigated
• 00840019938853: Reform MC Tap (6.5mm Screw), Non-Cannulated, Navigated
• 00840019938846: Reform MC Tap (5.5mm Screw), Non-Cannulated, Navigated
• 00840019938839: Reform MC Tap (5.0mm Screw), Non-Cannulated, Navigated
• 00840019938822: Reform MC Tap (4.5mm Screw), Non-Cannulated, Navigated
• 00840019938815: Reform MC Drill Guide, Navigated
• 00840019938808: Reform MC Drill (6.5mm Screw), Navigated
• 00840019938792: Reform MC Drill (5.5mm Screw), Navigated
• 00840019938785: Reform® MC Drill (5.0mm Screw), Navigated
• 00840019938778: Reform MC Drill (4.5mm Screw), Navigated
• 00840019939171: SureLOK MIS 3L Polyaxial Driver, Navigated
• 00840019939164: SureLOK MIS 3L Tap (9.5mm Screw), Navigated
• 00840019939157: SureLOK MIS 3L Tap (8.5mm Screw), Navigated
• 00840019939140: SureLOK MIS 3L Tap (7.5mm Screw), Navigated
• 00840019939133: SureLOK MIS 3L Tap (6.5mm Screw), Navigated
• 00840019939126: SureLOK MIS 3L Tap (5.5mm Screw), Navigated
• 00840019939119: SureLOK MIS 3L Tap (4.5mm Screw), Navigated
• 00840019939102: SureLOK MIS 3L Cannulated Awl, Navigated
• 00840019939096: Reform Ti Polyaxial Driver, Cannulated, Navigated
• 00840019939089: Reform Ti Polyaxial Driver, Non-Cannulated, Navigated
• 00840019939072: Reform Modular Driver, Non-Cannulated, Navigated
• 00840019939065: Reform HA Tap (9.5mm Screw), Non-Cannulated, Navigated
• 00840019939058: Reform HA Tap (8.5mm Screw), Non-Cannulated, Navigated
• 00840019939041: Reform HA Tap (7.5mm Screw), Non-Cannulated, Navigated
• 00840019939034: Reform HA Tap (6.5mm Screw), Non-Cannulated, Navigated
• 00840019939027: Reform HA Tap (5.5mm Screw), Non-Cannulated, Navigated
• 00840019939010: Reform HA Tap (4.5mm Screw), Non-Cannulated, Navigated
• 00840019939003: Reform Polyaxial Driver, Non-Cannulated, Navigated
• 00840019938990: Reform Tap (9.5mm Screw), Non-Cannulated, Navigated
• 00840019938983: Reform Tap (8.5mm Screw), Non-Cannulated, Navigated
• 00840019938976: ReformTap (7.5mm Screw), Non-Cannulated, Navigated
• 00840019938969: Reform Tap (6.5mm Screw), Non-Cannulated, Navigated
• 00840019938952: Reform Tap (5.5mm Screw), Non-Cannulated, Navigated
• 00840019938945: Reform Tap (4.5mm Screw), Non-Cannulated, Navigated