Dynamic Condylar Screw (D.C.S.)
510(k) K840954
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840954 | Date11 May 1984 | 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- Withdrawn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
- Full name
- Dynamic Condylar Screw or D.C.S.
- 510(k) Number
- FDA Product Code
- HRS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Dynamic Condylar Screw (D.C.S.) is an orthopedic device used for internal fixation. It is substantially equivalent to other devices in its class.
The device is supplied for use in orthopedic procedures, such as open reduction internal fixation (ORIF) and compression plating. It is available with an FDA 510K authorization and has a product code of HRS. The device is used in surgical settings, including those under regional or general anesthesia.
Other devices from Synthes (Usa)
Questions
AI-generated answers, 27 Sep 2026
What is the Dynamic Condylar Screw used for?
The Dynamic Condylar Screw is used for internal fixation in orthopedic procedures, such as open reduction internal fixation and compression plating, in surgical settings.
Is the Dynamic Condylar Screw supplied sterile?
The description does not specify sterility, but it is typically expected for devices used in surgical settings.
What is the regulatory authorization for the Dynamic Condylar Screw?
The Dynamic Condylar Screw has an FDA 510K authorization, indicating it is substantially equivalent to other devices in its class.