Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K091190 FDA 510(k)
- FDA Product Code
- JDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3010 FDA 510(k)
- Regulation Number
- 888.3010 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Universal Clamp Stainless Steel System is a cerclage and fixation device used in orthopedic applications. It is designed to provide secure fixation for various surgical procedures.
The system is supplied as stainless steel and is available in models SNA027-0-30060 and SNA027-0-30063. It received FDA 510(k) clearance with K091190 on July 30, 2009, and is classified under product code JDQ for orthopedic use.
Frequently asked questions
What is the Universal Clamp Stainless Steel System used for?
The Universal Clamp Stainless Steel System is a cerclage and fixation device designed for secure fixation in various orthopedic surgical procedures. It is supplied as stainless steel and available in two models: SNA027-0-30060 and SNA027-0-30063.
Is the Universal Clamp Stainless Steel System reusable or single-use?
The device data does not specify whether the Universal Clamp Stainless Steel System is reusable or single-use. The system is supplied as stainless steel, but additional information regarding reprocessing or single-use status would need to be obtained from the manufacturer.
What regulatory approvals does the Universal Clamp Stainless Steel System have?
The Universal Clamp Stainless Steel System received FDA 510(k) clearance with K091190 on July 30, 2009. It is classified under product code JDQ for orthopedic use and was determined to be substantially equivalent to predicate devices.
How is the Universal Clamp Stainless Steel System supplied?
The Universal Clamp Stainless Steel System is supplied as stainless steel and is available in two models: SNA027-0-30060 and SNA027-0-30063. The device data does not provide information about packaging configurations or quantities per package.
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: Universal Clamp Stainless Steel System, Models Sna027-0-30060, Sna027-0 ..., UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS… - FDA.report, PDF K091190 - Universal Clamp Stainless Steel System, Models Sna027-0-30060 ..., Device Listing 2037010488 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K091190 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Spine, Inc.
Sources (1)
- FDA 510(k) K091190 24 fields · synced Sep 22, 2026