Paeon Posterior Cervical Fixation System 6116-3534

GUDID 00840273306580

Cervical Reduction Screw Ø3.5x34mm (Ø3.0 Neck)

Aegis Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840273306580
• NIH Device Record Key: 6b01cec4-7d8a-4205-83df-bc186e5867e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paeon Posterior Cervical Fixation System
• Version Model Number: 6116-3534
• Catalog Number: 6116-3534
• Company DUNS: 017993061
• Company Name: Aegis Spine, Inc.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840273306580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210035

FDA Product Code

• NKG: Posterior Cervical Screw System

Sterilization

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

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

[00840273306580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

On-Brand Devices [Paeon Posterior Cervical Fixation System]

• 00840273305613: Cervical Semi Reduction Screw Ø4.0x50mm (Ø2.4 Neck)
• 00840273305606: Cervical Semi Reduction Screw Ø4.0x48mm (Ø2.4 Neck)
• 00840273305590: Cervical Semi Reduction Screw Ø4.0x46mm (Ø2.4 Neck)
• 00840273305583: Cervical Semi Reduction Screw Ø4.0x44mm (Ø2.4 Neck)
• 00840273305576: Cervical Semi Reduction Screw Ø4.0x42mm (Ø2.4 Neck)
• 00840273305569: Cervical Semi Reduction Screw Ø4.0x40mm (Ø2.4 Neck)
• 00840273305552: Cervical Semi Reduction Screw Ø4.0x38mm (Ø2.4 Neck)
• 00840273305545: Cervical Semi Reduction Screw Ø4.0x36mm (Ø2.4 Neck)
• 00840273305538: Cervical Semi Reduction Screw Ø4.0x34mm (Ø2.4 Neck)
• 00840273305521: Cervical Semi Reduction Screw Ø4.0x32mm (Ø2.4 Neck)
• 00840273305514: Cervical Semi Reduction Screw Ø4.0x30mm (Ø2.4 Neck)
• 00840273305507: Cervical Semi Reduction Screw Ø4.0x28mm (Ø2.4 Neck)
• 00840273305491: Cervical Semi Reduction Screw Ø4.0x26mm (Ø2.4 Neck)
• 00840273305484: Cervical Semi Reduction Screw Ø4.0x24mm (Ø2.4 Neck)
• 00840273305477: Cervical Semi Reduction Screw Ø4.0x22mm (Ø2.4 Neck)
• 00840273305460: Cervical Semi Reduction Screw Ø4.0x20mm (Ø2.4 Neck)
• 00840273305453: Cervical Semi Reduction Screw Ø4.0x18mm (Ø2.4 Neck)
• 00840273305446: Cervical Semi Reduction Screw Ø4.0x16mm (Ø2.4 Neck)
• 00840273305439: Cervical Semi Reduction Screw Ø4.0x14mm (Ø2.4 Neck)
• 00840273305422: Cervical Semi Reduction Screw Ø4.0x12mm (Ø2.4 Neck)
• 00840273305415: Cervical Semi Reduction Screw Ø4.0x10mm (Ø2.4 Neck)
• 00840273305408: Cervical Semi Reduction Screw Ø3.5x50mm (Ø2.4 Neck)
• 00840273305392: Cervical Semi Reduction Screw Ø3.5x48mm (Ø2.4 Neck)
• 00840273305385: Cervical Semi Reduction Screw Ø3.5x46mm (Ø2.4 Neck)
• 00840273305378: Cervical Semi Reduction Screw Ø3.5x44mm (Ø2.4 Neck)
• 00840273305361: Cervical Semi Reduction Screw Ø3.5x42mm (Ø2.4 Neck)
• 00840273305354: Cervical Semi Reduction Screw Ø3.5x40mm (Ø2.4 Neck)
• 00840273305347: Cervical Semi Reduction Screw Ø3.5x38mm (Ø2.4 Neck)
• 00840273305330: Cervical Semi Reduction Screw Ø3.5x36mm (Ø2.4 Neck)
• 00840273305323: Cervical Semi Reduction Screw Ø3.5x34mm (Ø2.4 Neck)
• 00840273305316: Cervical Semi Reduction Screw Ø3.5x32mm (Ø2.4 Neck)
• 00840273305309: Cervical Semi Reduction Screw Ø3.5x30mm (Ø2.4 Neck)
• 00840273305293: Cervical Semi Reduction Screw Ø3.5x28mm (Ø2.4 Neck)
• 00840273305286: Cervical Semi Reduction Screw Ø3.5x26mm (Ø2.4 Neck)
• 00840273305279: Cervical Semi Reduction Screw Ø3.5x24mm (Ø2.4 Neck)
• 00840273305262: Cervical Semi Reduction Screw Ø3.5x22mm (Ø2.4 Neck)
• 00840273305255: Cervical Semi Reduction Screw Ø3.5x20mm (Ø2.4 Neck)
• 00840273305248: Cervical Semi Reduction Screw Ø3.5x18mm (Ø2.4 Neck)
• 00840273305231: Cervical Semi Reduction Screw Ø3.5x16mm (Ø2.4 Neck)
• 00840273305224: Cervical Semi Reduction Screw Ø3.5x14mm (Ø2.4 Neck)
• 00840273305217: Cervical Semi Reduction Screw Ø3.5x12mm (Ø2.4 Neck)
• 00840273305200: Cervical Semi Reduction Screw Ø3.5x10mm (Ø2.4 Neck)
• 00840273305194: Cervical Polyaxial Screw Ø4.0x50mm (Ø3.0 Neck)
• 00840273305187: Cervical Polyaxial Screw Ø4.0x48mm (Ø3.0 Neck)
• 00840273305170: Cervical Polyaxial Screw Ø4.0x46mm (Ø3.0 Neck)
• 00840273305163: Cervical Polyaxial Screw Ø4.0x44mm (Ø3.0 Neck)
• 00840273305156: Cervical Polyaxial Screw Ø4.0x42mm (Ø3.0 Neck)
• 00840273305149: Cervical Polyaxial Screw Ø4.0x40mm (Ø3.0 Neck)
• 00840273305132: Cervical Polyaxial Screw Ø4.0x38mm (Ø3.0 Neck)
• 00840273305125: Cervical Polyaxial Screw Ø4.0x36mm (Ø3.0 Neck)