Reform POCT System 55-PM-4525

GUDID 00840019970785

Ø4.5 x 25mm Polyaxial Screw - M/L Bias

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840019970785
• NIH Device Record Key: 7ac2269b-75a5-4c55-a8e9-280327857c48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform POCT System
• Version Model Number: 55-PM-4525
• Catalog Number: 55-PM-4525
• 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: 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	00840019970785 [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

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

[00840019970785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

On-Brand Devices [Reform POCT System]

• 00840019927154: Add-on Instrument Sterilization Case
• 00840019927147: Occipital Rod Caddy
• 00840019927130: Occipital Screw Caddy
• 00840019927123: Occipital Plate Caddy
• 00840019927116: Hook Caddy
• 00840019927093: Cross-connector Caddy
• 00840019927086: Ø4.0mm Smooth Shank Screw Caddy
• 00840019927079: Ø3.5mm Smooth Shank Screw Caddy
• 00840019927062: Ø4.5mm Polyaxial Screw Caddy
• 00840019927055: Ø4.0mm Polyaxial Screw Caddy
• 00840019927048: Ø3.5mm Polyaxial Screw Caddy
• 00840019927024: Standard Rod Caddy
• 00840019927017: Occipital Instrument Sterilization Case
• 00840019927000: Standard Instrument Sterilization Case
• 00840019926966: Self-retaining Bone Screw Driver
• 00840019926959: Ø3.5mm Coronal Rod Bender, Right
• 00840019926935: Inline Counter Torque Wrench Assembly
• 00840019926928: Right Angle Counter Torque Wrench
• 00840019926911: Right Angle Torque Driver
• 00840019926898: Ø4.5mm Duckbill Probe, Straight
• 00840019926881: Ø4.0mm Bone Probe, Straight
• 00840019926874: Occipital Plate Counter Torque Wrench
• 00840019926867: Occipital Rod Bender - Hyperlordotic
• 00840019926850: T15 Occipital Screw Driver, Freehand - UV-Joint
• 00840019926843: T15 Occipital Screw Driver, Guided - UV-Joint
• 00840019926836: T15 Occipital Screw Driver - Straight
• 00840019926812: Ø4.5mm Occipital Bone Tap, Guided - UV-Joint
• 00840019926805: Ø4.5mm Occipital Bone Tap - Straight
• 00840019926799: Ø4.5mm Occipital Bone Drill, Guided - UV-Joint
• 00840019926782: Ø4.5mm Occipital Bone Drill - Straight
• 00840019926775: Variable Angle Guide
• 00840019926768: All-in-one Plate Inserter and Guide
• 00840019926751: Occipital Plate Bender
• 00840019926744: Occipital Plate Bending Iron Long
• 00840019926720: T-Handle Modular Torque Limiting Handle
• 00840019926713: Inline Modular Torque Indicating Handle
• 00840019926706: Inline Modular Torque Limiting Handle
• 00840019926683: Inline Modular Handle, Spin-cap
• 00840019926676: Distractor
• 00840019926669: Compressor
• 00840019926652: Laminar Elevator
• 00840019926645: Cross-connector and Domino Inserter
• 00840019926638: 55-IN-0136
• 00840019926621: Cross-connector Caliper
• 00840019926607: Cross-connector Inserter
• 00840019926591: Counter Torque Wrench
• 00840019926584: T15 Torque Driver
• 00840019926577: Single Sided Cap Screw Retention Driver
• 00840019926560: Dual-sided Cap Screw Inserter
• 00840019926546: Rod Reduction Rocker