Memory Staple
510(k) K060746
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060746 | Date25 May 2006 | StatusActive |
Official records
- FDA 510(k) database K060746
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDR
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
The Memory Staple is a bone fixation device intended for implantation in the foot. It is available in Memory 12 and Memory 20 models, with the Memory 12 staples indicated for osteotomies of the first phalanx of the foot and the Memory 20 staples indicated for arthrodesis of the foot.
The Memory Staple is supplied as an implantable device and is subject to regulatory authorization. It received FDA 510(k) clearance with the K060746 number on May 25, 2006, and is classified under product code JDR as a staple for bone fixation in the orthopedic medical specialty.
Devices cleared under K060746
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.