Reform Ti CT Modular MIS Pedicle Screw System 64-BK-0113

GUDID 00840019942331

Ø7.5 / 8.5mm Screw Kit

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
Primary Device ID00840019942331
NIH Device Record Key044bb1ce-5309-41cf-aec1-659492582a16
Commercial Distribution StatusIn Commercial Distribution
Brand NameReform Ti CT Modular MIS Pedicle Screw System
Version Model Number64-BK-0113
Catalog Number64-BK-0113
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS100840019942331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


[00840019942331]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

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

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

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