RENOIR Posterior Cervico-Thoracic Fixation System

GUDID 00841732104471

RENOIR™ Polyaxial Screw, 3.5 x 12mm

CTL MEDICAL CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00841732104471
• NIH Device Record Key: 26aba83d-29da-4d60-858b-a128bc016586
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RENOIR Posterior Cervico-Thoracic Fixation System
• Version Model Number: 012.1412
• 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

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841732104471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121136

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[00841732104471]

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: 2016-03-05

On-Brand Devices [RENOIR Posterior Cervico-Thoracic Fixation System]

• 00841732105010: Hex Socket Driver, 6.0
• 00841732105003: Counter Torque, Cross Connector
• 00841732104983: Reduction Screwhead Cutter
• 00841732104976: Distractor
• 00841732104952: Anti-Torque Tool
• 00841732104945: Driver, Torque Limiter, 3 N-m
• 00841732104938: Driver, Set Screw, Star
• 00841732104921: Rod Rocker Arm
• 00841732104914: Rod Persuader
• 00841732104907: Rod Pusher
• 00841732104891: Rod Bender, In-Situ, RH, D3.5
• 00841732104884: Rod Bender, In-Situ, LH, D3.5
• 00841732104877: Rod Bender, In-Situ, RH, D4.5
• 00841732104860: Rod Bender, In-Situ, LH, D4.5
• 00841732104853: Rod Bender
• 00841732104846: Rod Cutter
• 00841732104822: Alignment Tool / Rod Pusher
• 00841732104815: Driver, Screw
• 00841732104808: Driver, Reduction Screw
• 00841732104792: Driver, Polyaxial Screw
• 00841732104785: Tester, Curved
• 00841732104778: Tester, Straight
• 00841732104747: Depth Gauge
• 00841732104730: Tap, 3.0 x L14
• 00841732104723: Tap, 3.0 x L12
• 00841732104716: Tap, 3.0 x L10
• 00841732104693: Drill, D2.6 x L10mm
• 00841732104686: Drill, D2.6 x L14mm
• 00841732104679: Drill, D2.6 x L12mm
• 00841732104648: Straight Handle, Trilobe QC
• 00841732104631: Angled Hook(left), L17mm
• 00841732104624: Angled Hook(Right), L17mm
• 00841732104617: Lamina Hook, L16mm
• 00841732104600: RENOIR™ Polyaxial Screw, 4.0 x L24mm
• 00841732104594: RENOIR™ Polyaxial Screw, 4.0 x L22mm
• 00841732104587: RENOIR™ Polyaxial Screw, 4.0 x L20mm
• 00841732104570: RENOIR™ Polyaxial Screw, 4.0 x L18mm
• 00841732104563: RENOIR™ Polyaxial Screw, 4.0 x L16mm
• 00841732104556: RENOIR™ Polyaxial Screw, 4.0 x L14mm
• 00841732104549: RENOIR™ Polyaxial Screw, 4.0 x L12mm
• 00841732104532: RENOIR™ Polyaxial Screw, 4.0 x L10mm
• 00841732104525: RENOIR™ Polyaxial Screw, 3.5 x L22mm
• 00841732104518: RENOIR™ Polyaxial Screw, 3.5 x L20mm
• 00841732104501: RENOIR™ Polyaxial Screw, 3.5 x L18mm
• 00841732104495: RENOIR™ Polyaxial Screw, 3.5 x L16mm
• 00841732104488: RENOIR™ Polyaxial Screw, 3.5 x 14mm
• 00841732104471: RENOIR™ Polyaxial Screw, 3.5 x 12mm
• 00841732104464: RENOIR™ Polyaxial Screw, 3.5 x 10mm
• 00841732104457: RENOIR™ Polyaxial Screw, 3.5 x 8mm
• 00841732104440: Set Screw, Cap Head, Star, OD7 x L3.5mm