Cequence Anterior Cervical Plate 0222-0021

GUDID 00846468018160

HYBRID PLATE, 2-LEVEL

Pioneer Surgical Technology, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00846468018160
NIH Device Record Key8687e35f-4469-4a1a-8a17-cd3ba28e36b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCequence Anterior Cervical Plate
Version Model Number0222-0021
Catalog Number0222-0021
Company DUNS793384496
Company NamePioneer Surgical Technology, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com
Phone+1(906)226-9909
Emaillabeling@resolvesurg.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100846468018160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

[00846468018160]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-10

On-Brand Devices [Cequence Anterior Cervical Plate]

00846468066529CEQUENCE TEMPORARY FIXATION PIN FOR BONE SCREW
00846468048600Norvill Self-Centering Bone Awl
00846468018580CEQUENCE COUNTER TORQUE WRENCH II
00846468018573TORQUE LIMITING HANDLE
00846468018566CEQUENCE FIXED HANDLE SCREWDRIVER FOR DOUBLE BARREL DRILL GUIDE
00846468018542CEQUENCE MODULAR SCREWDRIVER SHAFT II W/AO FITTING
00846468018535Modular Screw Driver Shaft I w/AO Fitting
00846468018528SMALL STRAIGHT MODULAR RATCHETING HANDLE W/AO FITTING
00846468018511CEQUENCE MODULAR TAP II W/AO FITTING: 4.0MM
00846468018504Modular Drill, 1.9mmØ, 18mm
00846468018498Modular Drill, 1.9mmØ, 16mm
00846468018481Modular Drill, 1.9mmØ, 14mm
00846468018474Modular Drill, 1.9mmØ, 12mm
00846468018467Modular Drill, 1.9mmØ, 10mm
00846468018450CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 18MM
00846468018443CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 16MM
00846468018436CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 14MM
00846468018429CEQUENCE 2.5MM DIAMETER MODULAR DRILL II W/AO FITTING: 12MM
008464680184122.5mm Diameter Modular Drill w/AO Fitting: 18mm
008464680184052.5mm Diameter Modular Drill w/AO Fitting: 16mm
008464680183992.5mm Diameter Modular Drill w/AO Fitting: 14mm
008464680183822.5mm Diameter Modular Drill w/AO Fitting: 12mm
008464680183752.5mm Diameter Modular Drill w/AO Fitting: 10mm
00846468018368CEQUENCE FIXED HANDLE BONE AWL FOR DOUBLE BARREL DRILL GUIDE
00846468018351CEQUENCE END HOLES DOUBLE BARREL DRILL GUIDE W/ADJUSTABLE HANDLE
00846468018344CEQUENCE MIDDLE HOLES DOUBLE BARREL DRILL GUIDE W/ADJUSTABLE HANDLE
00846468018337CEQUENCE CONSTRAINED SINGLE BARREL DRILL GUIDE II
00846468018320Semi-Constrained Single Barrel Drill Guide II
00846468018313CEQUENCE TEMPORARY FIXATION PIN FOR BONE SCREW HOLE
00846468018306CEQUENCE TEMPORARY FIXATION SCREW-PIN
00846468018290CEQUENCE TEMPORARY FIXATION SCREW-PIN INSERTER / REMOVER
00846468018283CEQUENCE CERVICAL PLATE HOLDER
00846468018276CEQUENCE FRENCH PLATE BENDER
00846468018269HYBRID PLATE, 3-LEVEL
00846468018252HYBRID PLATE, 3-LEVEL
00846468018245HYBRID PLATE, 3-LEVEL
00846468018238HYBRID PLATE, 3-LEVEL
00846468018221HYBRID PLATE, 3-LEVEL
00846468018214HYBRID PLATE, 3-LEVEL
00846468018207HYBRID PLATE, 3-LEVEL
00846468018191HYBRID PLATE, 3-LEVEL
00846468018184HYBRID PLATE, 3-LEVEL
00846468018177HYBRID PLATE, 2-LEVEL
00846468018160HYBRID PLATE, 2-LEVEL
00846468018153HYBRID PLATE, 2-LEVEL
00846468018146HYBRID PLATE, 2-LEVEL
00846468018139HYBRID PLATE, 2-LEVEL
00846468018122HYBRID PLATE, 2-LEVEL
00846468018115HYBRID PLATE, 2-LEVEL
00846468018108HYBRID PLATE, 2-LEVEL
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