Veper System, Expedium System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103133 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 Veper System and Expedium System are classified as orthopedic spinal fixation devices (product code NKB) designed to provide mechanical stabilization of the spine. These systems incorporate closed polyaxial screws with varying geometries and sizes to immobilize thoracic, lumbar, and sacral segments, serving as adjuncts to spinal fusion procedures.
Used in clinical settings by surgeons, these systems support both open and percutaneous (minimally invasive surgery) approaches. The devices are supplied as reusable instrumentation, with no explicit sterility or single-use designation noted in regulatory filings. No MRI safety classification or specific storage instructions are provided in the available data.
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: VEPER SYSTEM, EXPEDIUM SYSTEM (K103133) — FDA 510 (k) | Innolitics, PDF EXPEDIUM 5.5 Spine System - SPINEMarketGroup, Expedium Spine System, Viper System, Viper 2 System (K111136) — Fda 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103133 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA 510(k) K103133 24 fields · synced Sep 19, 2026