OrthoCircle Spine Pedicel Screw System

GUDID 00810005110457

4.5 x 55m Polyaxial-Non-Reduction Screw Set incl. Set Screw

OrthoCircle Spine

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00810005110457
• NIH Device Record Key: 8951c665-f728-48c7-8cf1-58a2d2186e5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoCircle Spine Pedicel Screw System
• Version Model Number: PNR45055.S11
• Company DUNS: 040985864
• Company Name: OrthoCircle Spine
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005110457 [Primary]

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [OrthoCircle Spine Pedicel Screw System]

• 00810005110389: 4.5 x 20mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110457: 4.5 x 55m Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110594: 6.5 x 30mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110471: 5.5 x 20mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110730: 4.5 x 20mm Polyaxial-Reduction Screw Set incl. Set Screw