AESCULAP ABC Cervical Plating System
510(k) K974706
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SN | NumberK974706 | Date13 Mar 1998 | 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- Withdrawn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
- KWQ
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory committee
- Orthopedic
- FDA decision
- SN
Overview
AI-generated summary, 19 Sep 2026
The AESCULAP ABC Cervical Plating System is a dynamic, self-locking, self-drilling anterior cervical plating device designed for spinal stabilization. It is classified as an orthopedic fixation system intended to augment spinal stability and reduce graft-related complications during the fusion process, supporting cervical spine surgery.
This system is supplied sterile and intended for single-use, featuring a modular design with plates and screws for secure fixation. It is approved under FDA 510(k) clearance (K974706) and is intended for use in orthopedic surgical settings. Compatibility with MRI is not specified, and proper storage conditions must be followed as per manufacturer guidelines.
Other devices from Aesculap, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal surgeries is the AESCULAP ABC Cervical Plating System designed to support?
The system is specifically designed for anterior cervical spine surgeries where spinal stabilization is required. It helps augment stability and reduce complications related to graft fusion, making it suitable for procedures involving the cervical spine where secure fixation is critical.
Is the AESCULAP ABC Cervical Plating System reusable or intended for single-use?
The system is explicitly labeled for single-use only, meaning it should not be reused after a single surgical procedure. This ensures patient safety and maintains sterility, as it is supplied sterile from the manufacturer.
What materials or features make the plating system self-locking and self-drilling?
While the exact materials aren’t detailed in the provided data, the system is described as self-locking and self-drilling, meaning the screws and plate design allow for secure fixation without requiring additional tools or steps for threading or locking. This modular design simplifies surgical workflow by combining drilling and locking into one process.
How should the system be stored to maintain its integrity before use?
The manufacturer recommends following specific storage conditions to preserve sterility and functionality. Since it’s supplied sterile, it must be kept in a sealed, uncontaminated environment until use, as outlined in the accompanying instructions. Improper storage could compromise its performance or sterility.
Does the system include multiple plate or screw sizes, and if so, how are they configured?
The system features a modular design with plates and screws tailored for cervical spine fixation, though exact sizes or configurations (e.g., lengths, angles) aren’t specified in the data. The modularity suggests adaptability to different cervical levels or patient anatomies, but clinicians should refer to the manufacturer’s surgical technique guide for precise sizing and application details.