Nexlock Femoral Stem
by Nexmed, Inc.
510(k) K955171
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955171 | Date9 Feb 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- Withdrawn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
- JDG
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3360
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Nexlock Femoral Stem is a Prosthesis, Hip, Femoral Component, Cemented, Metal, classified as a Class II device with product code JDG. It is a substantially equivalent device, as described in its FDA 510K clearance.
The device is supplied by Nexmed, Inc. and has been cleared by the FDA. It is intended for use in orthopedic applications, specifically as a femoral component in hip prostheses. The device has a regulation number of 888.3360 and is registered with the FDA under several registration numbers, including 3007366790 and 3009732568.
Other devices from Nexmed, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the Nexlock Femoral Stem used for?
The Nexlock Femoral Stem is used as a femoral component in hip prostheses for orthopedic applications.
Is the Nexlock Femoral Stem supplied sterile?
The device data does not specify if the Nexlock Femoral Stem is supplied sterile, but it is intended for use in orthopedic applications where sterility is typically required.
What is the regulatory classification of the Nexlock Femoral Stem?
The Nexlock Femoral Stem is classified as a Class II device with product code JDG and regulation number 888.3360.