PICASSO MIS Spinal System

GUDID 00841732108455

PICASSO™ Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L45mm

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841732108455
NIH Device Record Keyfcbeeefb-266e-46d6-a24f-cab72ccef95c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePICASSO MIS Spinal System
Version Model Number016.1573
Company DUNS080138504
Company NameCTL MEDICAL CORPORATION
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(214)545-5820
Emailcomplaints@ctlmed.com

Device Dimensions

Length45 Millimeter
Length45 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841732108455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841732108455]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-07

On-Brand Devices [PICASSO MIS Spinal System]

00841732109001Cutter, Sleeve, Type 2
00841732108998Anti-Torque Device
00841732108981Hex Driver with Torque Limiting T-Handle, 4.5
00841732108974Hex Driver, Shaft, 1/4" Square Male QC, 4.5
00841732108967Hex Driver with Handle, Self-Retention, 4.5
00841732108950Hex Driver with Handle, 3.0
00841732108943Rod Inserter
00841732108936Alignment Tool, Percutaneous Screw Head
00841732108929Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention
00841732108912Hex Driver, Cannulated, 1/4" Square Male QC, 4.0
00841732108905Tap, Cannulated, 1/4" Square Male QC, 6.5
00841732108899Tap, Cannulated, 1/4" Square Male QC, 5.5
00841732108882Tap, Cannulated, 1/4" Square Male QC, 4.5
00841732108875Drill, Trilobe End, D3.4  (for 4.5/5.0/5.5 Screws)
00841732108868Dilator, ID14 x OD17mm
00841732108851Dilator, ID10 x OD14mm
00841732108844Dilator, ID1.8 x OD10mm
00841732108837Percutaneous Straight Rod, D6.0 x L200mm
00841732108820Percutaneous Straight Rod, D6.0 x L160mm
00841732108813Percutaneous Straight Rod, D6.0 x L150mm
00841732108806Percutaneous Straight Rod, D6.0 x L140mm
00841732108790Percutaneous Straight Rod, D6.0 x L130mm
00841732108783Percutaneous Straight Rod, D6.0 x L120mm
00841732108776Percutaneous Straight Rod, D6.0 x L110mm
00841732108769Percutaneous Straight Rod, D6.0 x L100mm
00841732108752Percutaneous Straight Rod, D6.0 x L90mm
00841732108745Percutaneous Straight Rod, D6.0 x L80mm
00841732108738Percutaneous Straight Rod, D6.0 x L70mm
00841732108721Percutaneous Straight Rod, D6.0 x L65mm
00841732108714Percutaneous Straight Rod, D6.0 x L60mm
00841732108707Percutaneous Straight Rod, D6.0 x L55mm
00841732108691Percutaneous Straight Rod, D6.0 x L50mm
00841732108684Percutaneous Straight Rod, D6.0 x L45mm
00841732108677Percutaneous Straight Rod, D6.0 x L40mm
00841732108660Percutaneous Straight Rod, D6.0 x L35mm
00841732108653Percutaneous Curved Rod, D6.0 x L150mm
00841732108646Percutaneous Curved Rod, D6.0 x L140mm
00841732108639Percutaneous Curved Rod, D6.0 x L130mm
00841732108622Percutaneous Curved Rod, D6.0 x L120mm
00841732108615Percutaneous Curved Rod, D6.0 x L110mm
00841732108608Percutaneous Curved Rod, D6.0 x L100mm
00841732108592Percutaneous Curved Rod, D6.0 x L95mm
00841732108585Percutaneous Curved Rod, D6.0 x L90mm
00841732108578Percutaneous Curved Rod, D6.0 x L85mm
00841732108561Percutaneous Curved Rod, D6.0 x L80mm
00841732108554Percutaneous Curved Rod, D6.0 x L75mm
00841732108547Percutaneous Curved Rod, D6.0 x L70mm
00841732108530Percutaneous Curved Rod, D6.0 x L65mm
00841732108523Percutaneous Curved Rod, D6.0 x L60mm
00841732108516Percutaneous Curved Rod, D6.0 x L55mm
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