Isola Closed Dual Rod Connector
by Depuyacromed 510(k)
Active
510(k) K003822
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003822 | Date8 Jan 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Isola Closed Dual Rod Connector is an orthopedic device classified under the product code KWP, designed as a spinal stabilization component. It serves to connect and secure dual spinal rods within spinal fixation systems, facilitating immobilization and alignment of the spine. This connector is intended for use in skeletally mature patients as part of spinal fusion procedures. Its closed design ensures secure rod engagement while minimizing potential complications from exposure or misalignment.
This device is supplied as a reusable medical instrument, intended for surgical use in orthopedic settings. It is cleared under FDA 510(k) clearance K003822 with a special panel review in the orthopedic advisory committee. The connector is not specified as MRI-safe or single-use in the available data. No additional regulatory markings or sterility requirements are explicitly stated beyond standard surgical instrument processing protocols. The device is referenced under the regulation number 888.3050.
Other devices from Depuyacromed
Questions
AI-generated answers, 1 Oct 2026
What is the Isola Closed Dual Rod Connector used for?
The Isola Closed Dual Rod Connector is designed as a spinal stabilization component to connect and secure dual spinal rods within spinal fixation systems. It is specifically intended for use in skeletally mature patients undergoing spinal fusion procedures, helping to maintain proper alignment and immobilization of the spine. Its closed design reduces risks associated with rod exposure or misalignment during surgery.
Is the Isola Closed Dual Rod Connector single-use or reusable?
The Isola Closed Dual Rod Connector is supplied as a reusable medical instrument. It is intended for surgical use in orthopedic settings and must adhere to standard surgical instrument processing protocols after each use. Reusability is common for orthopedic tools like this to ensure cost-effectiveness and compliance with regulatory guidelines.
What regulatory approval does the Isola Closed Dual Rod Connector have?
The Isola Closed Dual Rod Connector holds FDA 510(k) clearance under the reference number K003822. This clearance was granted following a special review by the Orthopedic Advisory Committee, confirming its substantial equivalence to a predicate device. The device falls under product code KWP and is regulated under the classification number 888.3050.
Does the Isola Closed Dual Rod Connector require special sterility handling?
The available data does not specify additional sterility requirements beyond standard surgical instrument processing protocols. Since it is reusable, it must be cleaned, disinfected, and sterilized between uses in accordance with established orthopedic surgical practices. Always follow facility-specific protocols to ensure proper sterilization and prevent contamination.
Is the Isola Closed Dual Rod Connector compatible with MRI imaging?
The provided information does not explicitly state whether the Isola Closed Dual Rod Connector is MRI-safe. If MRI compatibility is required for a patient, it is essential to verify this detail with the manufacturer or consult the device’s technical specifications or labeling. Always ensure the device’s materials and construction align with MRI safety standards if imaging is planned.