Identifiers
- 510(k) Number
- K182179 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AdvantageRib Anterior System is a bone fixation device classified as a Plate, Fixation, Bone under FDA regulation 888.3030. It is designed for the fixation, stabilization, and fusion of rib fractures and osteotomies in both normal and osteoporotic bone, providing structural support to promote proper healing.
This system is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It is regulated under FDA 510(k) clearance (K182179) with a decision of Substantially Equivalent (SESE), approved on November 16, 2018. The device adheres to standard orthopedic safety and sterility protocols for surgical 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: K182179 FDA 510 (k) - AdvantageRib Anterior System, AdvantageRib Anterior System (K182179) — FDA 510(k) | Innolitics, AdvantageRib Anterior System 510 (k) K182179 - FDA.report, PDF K182179 - AdvantageRib Anterior System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182179 | Class II | Active |
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Manufacturer
- Manufacturer
- Sig Medical Corp.
Sources (1)
- FDA 510(k) K182179 24 fields · synced Oct 6, 2026