Ace External Bone Clamp Part #S11
by Ace Orthopedic Manufacturing Co.
510(k) K791466
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791466 | Date16 Aug 1979 | 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- Withdrawn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
- JEC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Ace External Bone Clamp Part #S11 is an orthopedic device, classified as a component, traction, invasive device. It is used in orthopedic applications.
The device is supplied as a single unit, with a product code of JEC and a regulation number of 888.3040. It has been granted FDA 510K clearance, with a decision description of Substantially Equivalent, and is listed with a k number of K791466.
Other devices from Ace Orthopedic Manufacturing Co.
Questions
AI-generated answers, 21 Sep 2026
What is the Ace External Bone Clamp Part #S11 used for?
The Ace External Bone Clamp Part #S11 is used in orthopedic applications, specifically as a component, traction, invasive device.
Is the Ace External Bone Clamp Part #S11 supplied sterile?
The device data does not specify if the Ace External Bone Clamp Part #S11 is supplied sterile, but it is supplied as a single unit.
What is the regulatory status of the Ace External Bone Clamp Part #S11?
The Ace External Bone Clamp Part #S11 has been granted FDA 510K clearance, with a decision description of Substantially Equivalent, and is listed with a k number of K791466.
What is the product code of the Ace External Bone Clamp Part #S11?
The product code of the Ace External Bone Clamp Part #S11 is JEC, with a regulation number of 888.3040.