S4 Cervical Occipital Plate Spinal System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100147 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 S4 Cervical Occipital Plate Spinal System is an orthopedic implant device classified as a spinal fixation system. It is designed to provide structural support and stabilization for the cervical and occipital spine, including the occipito-cervico-thoracic junction, to facilitate spinal fusion. Components include plates, bone screws, rods, hooks, and connectors, enabling customizable configurations for surgical applications. This system is intended for use in clinical settings to address spinal instability or deformity requiring internal fixation.
This device is supplied sterile and intended for single-use in surgical environments. It is regulated under FDA 510(k) clearance (K100147) as substantially equivalent to a predicate device, with approval for use in the cervical and thoracic spine regions (C1–T3). Components are designed for compatibility with standard surgical techniques and may require intraoperative adjustments based on anatomical requirements. Storage and handling follow sterile medical device protocols as specified by the manufacturer.
Frequently asked questions
What is the S4 Cervical Occipital Plate Spinal System used for?
This system is designed to provide structural support and stabilization for the cervical and occipital spine, including the occipito-cervico-thoracic junction. It is intended for surgical spinal fusion in cases of spinal instability or deformity, ensuring proper alignment and fixation during recovery.
Is the S4 Cervical Occipital Plate Spinal System supplied sterile and for single-use?
Yes, the system is supplied sterile and intended exclusively for single-use in surgical environments. This ensures patient safety by preventing cross-contamination and maintaining device integrity during procedures.
What components does the S4 Cervical Occipital Plate Spinal System include?
The system includes plates, bone screws, rods, hooks, and connectors. These modular components allow for customizable configurations tailored to specific anatomical requirements during surgery, enabling precise fixation in the cervical and occipital regions.
What regions of the spine is this system approved for?
The S4 Cervical Occipital Plate Spinal System is approved for use in the cervical and thoracic spine regions, specifically from C1 through T3. This range ensures compatibility with surgical needs spanning the upper spine and occipital base.
How should the S4 Cervical Occipital Plate Spinal System be stored?
Storage and handling must follow sterile medical device protocols as specified by the manufacturer. This includes maintaining sealed packaging, protecting from contamination, and adhering to temperature and humidity guidelines to preserve sterility and functionality before use.
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: S4® Spinal System - B. Braun, S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM (K100147) — FDA 510(k ..., K100147 - S4 Cervical Occipital Plate Spinal System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100147 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap Implant System, Inc.
Sources (1)
- FDA 510(k) K100147 24 fields · synced Oct 1, 2026