Monotube Tube-to-Tube Clamp
510(k) K954667
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK954667 | Date11 Jan 1996 | 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- Withdrawn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, 22 Sep 2026
The Monotube Tube-to-Tube Clamp is a component used in orthopedic applications as part of traction systems. It is designed to connect tubes in invasive procedures, providing a secure attachment point for medical devices.
This device is supplied as a single-use or reusable component, depending on the specific application. It is manufactured by Howmedica Corp. and has FDA 510(k) clearance under product code JEC with regulation number 888.3040. The device is available in various sizes and models as specified by the manufacturer.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the Monotube Tube-to-Tube Clamp used for?
The Monotube Tube-to-Tube Clamp is a component designed for orthopedic applications as part of traction systems. It provides a secure attachment point for medical devices by connecting tubes during invasive procedures.
Is the Monotube Tube-to-Tube Clamp single-use or reusable?
The Monotube Tube-to-Tube Clamp can be supplied as either a single-use or reusable component, depending on the specific application requirements and the manufacturer's specifications.
What sizes and models are available for the Monotube Tube-to-Tube Clamp?
The Monotube Tube-to-Tube Clamp is available in various sizes and models as specified by the manufacturer, Howmedica Corp., to accommodate different orthopedic applications and procedural needs.
What regulatory clearance does the Monotube Tube-to-Tube Clamp have?
The Monotube Tube-to-Tube Clamp has FDA 510(k) clearance under product code JEC with regulation number 888.3040. It was determined to be substantially equivalent to predicate devices for orthopedic applications.