Syntec OS Spinal Fixation System 824001

GUDID 04719873285167

Set Screw H5.0mm

SYNTEC SCIENTIFIC CORPORATION

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 04719873285167
• NIH Device Record Key: 23dc3f72-5783-4e71-b625-08fd64bea171
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syntec OS Spinal Fixation System
• Version Model Number: 824001
• Catalog Number: 824001
• Company DUNS: 657692971
• Company Name: SYNTEC SCIENTIFIC 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873285167 [Primary]

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[04719873285167]

Moist Heat or Steam Sterilization

[04719873285167]

Moist Heat or Steam Sterilization

[04719873285167]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

On-Brand Devices [Syntec OS Spinal Fixation System]

• 04719873287833: Smooth Rodφ5.5 x L120mm
• 04719873287796: Smooth Rodφ5.5 x L100mm
• 04719873286607: Polyaxial Long Arm Pedicle Screwφ5.0 x L40mm
• 04719873285167: Set Screw H5.0mm
• 04719873284986: Polyaxial Pedicle Screwφ6.5 x L45mm
• 04716873713751: Cross-Link 50/70mm