Advanced Revision Product Line Extension
by Wrightmedicaltechnologyinc 510(k)
Active
510(k) K990030
Overview
The Advanced Revision Product Line Extension is an orthopedic device. It is classified under the product code JWH. The device is substantially equivalent and has an abbreviated clearance type.
The device is supplied by Wright Medical Technology, Inc. and has been assigned the K number K990030. It is listed under the FDA with the clearance type being abbreviated. The device has been cleared by the FDA with a 510K clearance.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990030 | Date3 Feb 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JWH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3560
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wrightmedicaltechnologyinc
Questions
What is the Advanced Revision Product Line Extension used for?
The Advanced Revision Product Line Extension is used in orthopedic applications, as classified under the product code JWH.
How is the device supplied?
The device is supplied by Wright Medical Technology, Inc.
What is the regulatory status of the device?
The device has been cleared by the FDA with a 510K clearance, indicating it is substantially equivalent to a predicate device.
What is the product code for the device?
The product code for the Advanced Revision Product Line Extension is JWH, classified under the orthopedic advisory committee.