OrthoCircle Spine Pedicle Screw System

GUDID 00810005110501

5.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw

OrthoCircle Spine

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 00810005110501
• NIH Device Record Key: 689cb6b5-12a2-4311-930d-e632f4066522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OrthoCircle Spine Pedicle Screw System
• Version Model Number: PNR55035.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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810005110501 [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: 2020-04-06
• Device Publish Date: 2020-03-29

On-Brand Devices [OrthoCircle Spine Pedicle Screw System]

• 10810005111246: Set Screw
• 00810005111232: Rod Curved 5.5mm x 30mm
• 00810005111225: Rod Curved 5.5mm x 35mm
• 00810005111201: Rod Curved 5.5mm x 45mm
• 00810005111195: Rod Curved 5.5mm x 55mm
• 00810005111188: Rod Curved 5.5mm x 50mm
• 00810005111171: Rod Curved 5.5mm x 65mm
• 00810005111164: Rod Curved 5.5mm x 60mm
• 00810005111157: Rod Curved 5.5mm x 70mm
• 00810005111133: Rod Curved 5.5mm x 80mm
• 00810005111119: Rod Curved 5.5mm x 90mm
• 00810005111102: Rod Curved 5.5mm x 100mm
• 00810005110716: 7.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110709: 7.5 x 55mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110693: 7.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110686: 7.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110679: 7.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110624: 6.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110617: 6.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110563: 6.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110525: 5.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110518: 5.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110501: 5.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110495: 5.5 x 30mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110587: 6.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw
• 00810005110112: 5.5mm Tap
• 00810005110105: 101.111
• 00810005110099: Sounder - curved
• 00810005110082: Sounder - Straight
• 00810005110075: Pedicle Probe - Curved
• 00810005110068: Pedicle Probe - Straight
• 00810005110051: Pedicle Probe - Duck Bill
• 00810005110044: Palm Handle
• 00810005110037: Locking driver Shaft
• 00810005110020: Set Screw Driver
• 00810005110013: T-Handle - Ratcheting
• 00810005110006: Inline Handle - Ratcheting
• 00810005110167: Pistol Persuader
• 00810005110150: French Bender
• 00810005110143: Rod Fork
• 00810005110136: 7.5mm Tap
• 00810005110129: 6.5mm Tap
• 00810005111645: 60mm Rod Trial
• 00810005111638: Trial Rod Caddy
• 00810005111614: 50mm Rod Trial
• 00810005110440: 4.5 x 50mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110433: 4.5 x 40mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110426: 4.5 x 45mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110419: 4.5 x 35mm Polyaxial-Non-Reduction Screw Set incl. Set Screw
• 00810005110402: 4.5 x 30mm Polyaxial-Non-Reduction Screw Set incl. Set Screw