Impactor Large

GUDID 00810131882068

SR12- ION Facet Screw System

SURGENTEC, LLC

Facet joint prosthesis

• Primary Device ID: 00810131882068
• NIH Device Record Key: 69197e96-ffaa-4c0f-8e0f-45e6c76466df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impactor Large
• Version Model Number: SR12-6401
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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	00810131882068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243265

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

[00810131882068]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

Devices Manufactured by SURGENTEC, LLC

• 00081013188039 - ION AO Coupling Cannulated Handle: 2026-03-17 SR12- ION Facet Screw System
• 00810131880330 - T-Handle 3/16" Connection: 2026-03-17
• 00810131881252 - 6.5/7.0 Drill Bit: 2026-03-17 SR12- ION Facet Screw System
• 00810131881429 - OsteoFlo HydroFiber - 1cc Labeled: 2026-03-17
• 00810131881436 - OsteoFlo HydroFiber - 3cc Labeled: 2026-03-17
• 00810131881443 - OsteoFlo HydroFiber - 6cc Labeled: 2026-03-17
• 00810131881450 - OsteoFlo HydroFiber - 12cc Labeled: 2026-03-17
• 00810131881726 - ION Facet Screw System: 2026-03-17 ION Facet Screw - 7.0 x 10mm