Reform Ti CT Modular MIS Pedicle Screw System 64-PM-6545

GUDID 00840019971829

6.5 X 45mm Reform MC MIS Screw Assembly, Cannulated

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840019971829
• NIH Device Record Key: cb0f48d4-3bca-49ca-821e-d4b0d1bdc4ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reform Ti CT Modular MIS Pedicle Screw System
• Version Model Number: 64-PM-6545
• Catalog Number: 64-PM-6545
• 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	00840019971829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200303

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

[00840019971829]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [Reform Ti CT Modular MIS Pedicle Screw System]

• 00840019942768: T30 Lock-Screw
• 00840019942751: Modular MIS Reduction Tulip
• 00840019942744: Modular MIS Base Tulip
• 00840019942638: Parallel Compressor/Distractor
• 00840019942621: M/L Compressor/Distractor Pivot
• 00840019942614: M/L Compressor/Distractor
• 00840019942607: Compressor/Distractor Handle
• 00840019942591: Tower Remover
• 00840019942584: Rescue Tower Guide
• 00840019942577: Rescue Tower
• 00840019942560: Counter Torque Wrench
• 00840019942553: Torque Driver, Short - T30
• 00840019942546: Tab Breaker
• 00840019942539: Ring Remover
• 00840019942522: Rod Inserter, Long
• 00840019942515: Rod Inserter
• 00840019942508: Caliper
• 00840019942492: Tulip Adjuster
• 00840019942485: Lock-Screw Starter, Threaded - T30
• 00840019942478: Lock-Screw Starter - T30
• 00840019942461: Adjustment Driver - T25
• 00840019942454: Polyaxial Driver - T25
• 00840019942447: Tissue Cutter
• 00840019942430: Tissue Splitter Blade
• 00840019942423: Tissue Splitter
• 00840019940610: Modular MIS Extended Tab Tulip
• 00840019942720: Palm Grip Handle
• 00840019942713: Custom Dynamo Handle
• 00840019942706: Standard Dynamo Handle
• 00840019942690: Torque Limiting T-Handle (90 in-lbs) - Blue
• 00840019942683: Ratcheting T-Handle
• 00840019942676: Ratcheting Palm Handle
• 00840019942669: Rod Reducer Driver
• 00840019942652: Rod Reducer Sleeve
• 00840019942645: Torque Driver, Long - T30
• 00840019942393: Guide Wire Tube Kit
• 00840019942386: Tower Instrument Kit
• 00840019942379: Extended Tab Tulip Instrument Kit
• 00840019942362: Ø5.5mm Lordotic Rod Kit
• 00840019942355: Standard / Reduction Tulip Kit
• 00840019942348: Extended Tab Tulip Kit
• 00840019942331: Ø7.5 / 8.5mm Screw Kit
• 00840019942324: Ø5.5 / 6.5mm Screw Kit
• 00840019942317: Lock-Screw Kit
• 00840019942300: Standard/Reduction/Extended Tab Tulip Implant Kit
• 00840019942294: Standard/Reduction Tulip Implant Kit
• 00840019942287: Extended Tab Tulip Implant Kit
• 00840019942270: Mini Open Instrument Sterilization Case
• 00840019942263: Add-on Instrument Sterilization Case
• 00840019942256: Guide Wire Tube