Reform POCT System 55-BK-0201

GUDID 00840019937016

Standard Instrument Kit

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019937016
• NIH Device Record Key: 1d9e2a80-4c6a-4112-8193-a637a9286acc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform POCT System
• Version Model Number: 55-BK-0201
• Catalog Number: 55-BK-0201
• 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	00840019937016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162300

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00840019937016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-09
• Device Publish Date: 2019-08-30

On-Brand Devices [Reform POCT System ]

• 00815362024621: Ø3.5 x 25mm Lateral Offset, Open
• 00815362024614: Ø3.5 x 15mm Lateral Offset, Open
• 00815362024607: Ø3.5 x 25mm Lateral Offset, Closed
• 00815362024591: Ø3.5 x 15mm Lateral Offset, Closed
• 00815362024584: Ø6.0mm, Supra Laminar Offset Hook Left
• 00815362024577: Ø6.0mm, Supra Lamniar Offset Hook Right
• 00815362024560: Ø6.0mm, Offset Hook Left
• 00815362024553: Ø6.0mm, Offset Hook Right
• 00815362024546: Ø6.0mm, Straight Hook
• 00815362024539: Ø4.5mm, Supra Laminar Offset Hook Left
• 00815362024515: Ø4.5mm, Offset Hook Left
• 00815362024508: Ø4.5mm, Offset Hook Right
• 00815362024485: Ø4.0 x 40mm Smooth Shank Screw
• 00815362024478: Ø4.0 x 38mm Smooth Shank Screw
• 00815362024461: Ø4.0 x 36mm Smooth Shank Screw
• 00815362024454: Ø4.0 x 34mm Smooth Shank Screw
• 00815362024447: Ø4.0 x 32mm Smooth Shank Screw
• 00815362024430: Ø4.0 x 30mm Smooth Shank Screw
• 00815362024423: Ø4.0 x 28mm Smooth Shank Screw
• 00815362024416: Ø4.0 x 26mm Smooth Shank Screw
• 00815362024409: Ø4.0 x 24mm Smooth Shank Screw
• 00815362024393: Ø4.0 x 22mm Smooth Shank Screw
• 00815362024386: Ø4.0 x 20mm Smooth Shank Screw
• 00815362024379: Ø3.5 x 40mm Smooth Shank Screw
• 00815362024362: Ø3.5 x 38mm Smooth Shank Screw
• 00815362024355: Ø3.5 x 36mm Smooth Shank Screw
• 00815362024348: Ø3.5 x 34mm Smooth Shank Screw
• 00815362024331: Ø3.5 x 32mm Smooth Shank Screw
• 00815362024324: Ø3.5 x 30mm Smooth Shank Screw
• 00815362024317: Ø3.5 x 28mm Smooth Shank Screw
• 00815362024300: Ø3.5 x 26mm Smooth Shank Screw
• 00815362024294: Ø3.5 x 24mm Smooth Shank Screw
• 00815362024287: Ø3.5 x 22mm Smooth Shank Screw
• 00815362024270: Ø3.5 x 20mm Smooth Shank Screw
• 00815362024263: Ø4.5 x 50mm Polyaxial Screw
• 00815362024256: Ø4.5 x 45mm Polyaxial Screw
• 00815362024249: Ø4.5 x 40mm Polyaxial Screw
• 00815362024232: Ø4.5 x 35mm Polyaxial Screw
• 00815362024225: Ø4.5 x 30mm Polyaxial Screw
• 00815362024218: Ø4.5 x 25mm Polyaxial Screw
• 00815362024201: Ø4.5 x 20mm Polyaxial Screw
• 00815362024195: Ø4.0 x 40mm Polyaxial Screw
• 00815362024188: Ø4.0 x 35mm Polyaxial Screw
• 00815362024171: Ø4.0 x 30mm Polyaxial Screw
• 00815362024164: Ø4.0 x 28mm Polyaxial Screw
• 00815362024157: Ø4.0 x 26mm Polyaxial Screw
• 00815362024140: Ø4.0 x 24mm Polyaxial Screw
• 00815362024133: Ø4.0 x 22mm Polyaxial Screw
• 00815362024126: Ø4.0 x 20mm Polyaxial Screw
• 00815362024119: Ø4.0 x 18mm Polyaxial Screw