Identifiers
- 510(k) Number
- K041203 FDA 510(k)
- FDA Product Code
- MNI 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 Summit OCT Spinal System is an orthopedic device classified as an Occipito-Cervico-Thoracic (OCT) spinal fixation system. It is designed for posterior stabilization of the upper spine, providing fixation, alignment, and extension through surgical implants and instrumentation tailored for the occipital, cervical, and thoracic regions.
This system is supplied as a surgical implant and instrumentation kit, intended for single-use in spinal surgery settings. It is regulated under FDA 510(k) clearance (K041203) and is intended for use in orthopedic procedures. The device is not labeled as MRI-safe, and sterility is ensured through manufacturer-provided packaging. Storage and handling follow standard surgical instrument protocols as specified by the manufacturer.
Frequently asked questions
What specific regions of the spine is the Summit OCT Spinal System designed to stabilize, and how does it achieve this?
The Summit OCT Spinal System is specifically designed for posterior stabilization of the occipital, cervical, and thoracic regions of the upper spine. It achieves this through surgical implants and instrumentation tailored to these areas, providing fixation, alignment, and structural support during orthopedic procedures.
Is the Summit OCT Spinal System intended for reuse, or is it meant to be used only once in a surgical setting?
The Summit OCT Spinal System is explicitly supplied as a single-use device for spinal surgery. This ensures sterility and safety per manufacturer-provided packaging, adhering to standard surgical instrument protocols.
How is sterility maintained for the Summit OCT Spinal System, and what storage guidelines should be followed?
Sterility is maintained through manufacturer-provided packaging designed for single-use. Storage and handling must follow standard surgical instrument protocols as outlined by Depuy Spine to preserve sterility and functionality before use.
Can the Summit OCT Spinal System be used in MRI scans after implantation, or does it pose any risks?
The Summit OCT Spinal System is not labeled as MRI-safe, meaning it should not be used in MRI environments due to potential risks such as heating or image artifacts. Clinicians should verify compatibility with their specific MRI protocols before considering use.
What regulatory pathway was followed for the Summit OCT Spinal System, and what does this mean for its use in clinical settings?
The Summit OCT Spinal System was cleared via the FDA 510(k) pathway (K041203), determined to be *substantially equivalent* to a predicate device under a Special 510(k) review. This clearance allows its use in orthopedic procedures for posterior stabilization of the upper spine, subject to standard surgical guidelines and manufacturer instructions.
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: Johnson & Johnson DePuy Synthes SUMMIT SI Manual, Spine | DePuy Synthes, Johnson & Johnson DePuy Synthes SUMMIT SI Manuals, PDF Summit OCT Spinal System and Mountaineer OCT Spinal System - Additional ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041203 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA 510(k) K041203 24 fields · synced Sep 19, 2026