OrthoCircle Spine Pedicle Screw System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193472 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OrthoCircle Spine Pedicle Screw System is a thoracolumbosacral spinal fixation system, containing devices intended for use as a posterior pedicle screw fixation system. It consists of titanium alloy poly-axial screws, rods, and set screws, and is used to provide structural support to the spine during fusion procedures.
The system is supplied for use in clinical settings by surgeons. It is a Class 2 Orthopedic device with product code NKB. The device has FDA 510K authorizations and is cleared through the Traditional 510(k) pathway.
Frequently asked questions
What is the OrthoCircle Spine Pedicle Screw System used for?
The system is used to provide structural support to the spine during fusion procedures, specifically as a posterior pedicle screw fixation system.
What materials are used in the OrthoCircle Spine Pedicle Screw System?
The system consists of titanium alloy poly-axial screws, rods, and set screws.
Is the OrthoCircle Spine Pedicle Screw System cleared for use in clinical settings?
Yes, the system has FDA 510K authorizations and is cleared through the Traditional 510(k) pathway for use in clinical settings by surgeons.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF INSTRUCTIONS FOR USE OrthoCircle Spine Pedicle Screw System, OrthoCircle Spine Pedicle Screw System (K193472) - Innolitics, K193472 FDA 510(k) - OrthoCircle Spine Pedicle Screw System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193472 | Class II | Active |
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Manufacturer
- Manufacturer
- OrthoCircle Spine
Sources (1)
- FDA 510(k) K193472 24 fields · synced Sep 27, 2026