Reform MC Screw System 59-RD-0420

GUDID 00840019930796

Tower Reducer

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019930796
NIH Device Record Key8ef3f7d6-6cce-4419-bf02-fbfba5e176fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform MC Screw System
Version Model Number59-RD-0420
Catalog Number59-RD-0420
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019930796 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

[00840019930796]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

On-Brand Devices [Reform MC Screw System]

00840019927994Modular Screw Driver
00840019927987Adjustment Screw Driver
00840019927970Ø6.5mm Power Bone Drill
00840019927963Ø5.5mm Power Bone Drill
00840019927956Ø5.0mm Power Bone Drill
00840019927932Ø6.5mm Cortical Drill
00840019927895Tulip Manipulator
00840019927888Drill Guide, Adjustable
00840019927871Outlier Drill Guide, Adjustable
00840019927864Bone Awl
00840019927857Blade Depth Indicator
00840019927840Ball Tip Sounder, Straight
00840019927833Midline Blade Inserter
00840019927826Midline Retractor Assembly
00840019927819Puppet Leg Distractor
00840019927802Bone Awl
00840019927796T-Handle Reducer
00840019927789Trajectory Tube Assembly
00840019927772Reduction Tower
00840019927765Reduction Gun
00840019927758Rod Holder
00840019927741Rod Pusher
00840019927734Counter-Torque
00840019927710In Situ Bender, Left
00840019927703Parallel Distractor
00840019927680Flexible Rod - 250mm
00840019927666Flexible Rod Template -Ø3.5mm
00840019927642Double Level Blade, Right, 110mm
00840019927635Double Level Blade, Right, 100mm
00840019927628Double Level Blade, Right, 90mm
00840019927604Double Level Blade, Right, 70mm
00840019927598Double Level Blade, Right, 60mm
00840019927581Double Level Blade, Right, 50mm
00840019927574Double Level Blade, Right, 40mm
00840019927567Single Level Blade, Right, 110mm
00840019927543Single Level Blade, Right, 90mm
00840019927536Single Level Blade, Right, 80mm
00840019927512Single Level Blade, Right, 60mm
00840019927505Single Level Blade, Right, 50mm
00840019927499Single Level Blade, Right, 40mm
00840019927482Modular Screw Driver
00840019927475Ø9.5mm Cannulated Screw Tap
00840019927468Ø8.5mm Cannulated Screw Tap
00840019927451Ø7.5mm Cannulated Screw Tap
00840019927413Ø4.5mm Cannulated Screw Tap
00840019927406Double Level Blade, Left, 110mm
00840019927390Double Level Blade, Left, 100mm
00840019927383Double Level Blade, Left, 90mm
00840019927376Double Level Blade, Left, 80mm
00840019927369Double Level Blade, Left, 70mm
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