PICASSO II MIS Spinal System

GUDID 00841732109124

PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L45mm

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732109124
• NIH Device Record Key: 56a33bd1-5af6-4e9b-ac1f-9e29f8b503ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PICASSO II MIS Spinal System
• Version Model Number: 019.1553
• Company DUNS: 080138504
• Company Name: CTL MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: false
• 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

Customer Support Contacts

• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: complaints@ctlmed.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com
• Phone: +1(214)545-5820
• Email: schedule@ctlamedica.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732109124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140219

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

[00841732109124]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-07

On-Brand Devices [PICASSO II MIS Spinal System]

• 00841732109490: Distractor
• 00841732109483: Compressor
• 00841732109476: Hex Driver with Torque Limiting T-Handle, 5.0 (12 N-m)
• 00841732109469: Hex Driver, 1/4" Square QC, 5.0 with Shoulder
• 00841732109452: Hex Driver with Handle, 5.0 with Shoulder
• 00841732109445: Hex Driver, 1/4" Square QC, 4.0, Cannulated
• 00841732109438: Tap, Cannulated, 1/4" Square QC, 7.5
• 00841732109421: Tap, Cannulated, 1/4" Square QC, 6.5
• 00841732109414: Tap, Cannulated, 1/4" Square QC, 5.5
• 00841732109407: Tap, Cannulated, 1/4" Square QC, 4.5
• 00841732109391: Tap, 1/4" Square QC, 7.5
• 00841732109384: Tap, 1/4" Square QC, 6.5
• 00841732109377: Tap, 1/4" Square QC, 5.5
• 00841732109360: Tap, 1/4" Square QC, 4.5
• 00841732109353: Drill, Cannulated, 1/4" Square QC, D5.0mm
• 00841732109346: Drill, Cannulated, 1/4" Square QC, D4.2mm
• 00841732109339: Drill, Cannulated, 1/4" Square QC, D3.4mm
• 00841732109322: Drill, 1/4" Square QC, D5.0mm
• 00841732109315: Drill, 1/4" Square QC, D4.2mm
• 00841732109308: Drill, 1/4" Square QC, D3.4mm
• 00841732109292: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L60mm
• 00841732109285: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L55mm
• 00841732109278: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L50mm
• 00841732109261: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L45mm
• 00841732109254: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L40mm
• 00841732109247: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L35mm
• 00841732109230: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L30mm
• 00841732109223: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L60mm
• 00841732109216: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L55mm
• 00841732109209: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L50mm
• 00841732109193: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L45mm
• 00841732109186: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L40mm
• 00841732109179: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L35mm
• 00841732109162: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L30mm
• 00841732109155: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L60mm
• 00841732109148: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L55mm
• 00841732109131: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L50mm
• 00841732109124: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L45mm
• 00841732109117: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L40mm
• 00841732109100: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L35mm
• 00841732109094: PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L30mm
• 00841732109087: Set Screw, Polyaxial Screwhead