Cradle Fixation Device
510(k) K941772
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941772 | Date7 Aug 1995 | 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- Withdrawn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
- JDR
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Cradle Fixation Device is a bone fixation staple used in orthopedic procedures. It is designed to provide secure fixation for bone tissue.
This device is identified by FDA 510(k) number K941772 and is classified as a class 2 medical device. It is manufactured by Neoligaments, Ltd. and received FDA 510(k) clearance on August 7, 1995.
Other devices from Neoligaments, Ltd.
Questions
AI-generated answers, 21 Sep 2026
What is the primary clinical use of the Cradle Fixation Device?
The Cradle Fixation Device is designed as a bone fixation staple intended for use during orthopedic surgical procedures. Its primary function is to provide secure fixation for bone tissue.
What is the regulatory status of this device?
The Cradle Fixation Device is a class 2 medical device that received FDA 510(k) clearance on August 7, 1995, under the submission number K941772.
Who is the manufacturer of the Cradle Fixation Device?
This device is manufactured by Neoligaments, Ltd., which is based in Leeds, United Kingdom.