Cable-Ease Plate And Cable System
510(k) K944529
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK944529 | Date17 Feb 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3010
- Advisory Committee
- Orthopedic
- FDA Decision
- SN
Overview
AI-generated summary, 26 Sep 2026
The Cable-Ease Plate And Cable System is a device classified as a Cerclage, Fixation device. It is used for orthopedic indications.
The device is supplied by Intermedics Orthopedics and has been cleared by the FDA with a 510(k) clearance, specifically K944529. The device has a product code of JDQ and is classified as a Class II device with special controls.
Other devices from Intermedics Orthopedics
Questions
AI-generated answers, 26 Sep 2026
What is the Cable-Ease Plate And Cable System used for?
The Cable-Ease Plate And Cable System is used for orthopedic indications, providing fixation and cerclage capabilities.
How is the Cable-Ease Plate And Cable System supplied?
The device is supplied by Intermedics Orthopedics, with a product code of JDQ and classified as a Class II device with special controls.
What is the regulatory status of the Cable-Ease Plate And Cable System?
The device has been cleared by the FDA with a 510(k) clearance, specifically K944529, indicating substantial equivalence for some indications.