Rebound Hrd
by Minnesota Medical Development, Inc.
510(k) K063671
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063671 | Date16 Aug 2007 | 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- Withdrawn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
- FTL
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
The Rebound Hrd is a polymeric surgical mesh device. It is classified as a prosthetic device intended for use in general and plastic surgery applications.
This device is subject to FDA 510(k) clearance. It is regulated under 21 CFR 878.3300 and is associated with product code FTL.
Other devices from Minnesota Medical Development, Inc.
Questions
AI-generated answers, 26 Sep 2026
What is the intended use of the Rebound Hrd?
The Rebound Hrd is a polymeric surgical mesh classified as a prosthetic device. It is specifically intended for use in general and plastic surgery applications.
What is the regulatory status of this device?
The Rebound Hrd is subject to FDA 510(k) clearance. It is regulated under 21 CFR 878.3300 and is categorized under product code FTL.
Who is the manufacturer of the Rebound Hrd?
The Rebound Hrd is manufactured by Minnesota Medical Development, Inc., located in Stillwater, Minnesota.