AESUCLAP SOCON Spinal System (K970285)
510(k) K970285
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970285 | Date25 Jun 1997 | 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- Withdrawn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
- Aesuclap Socon Spinal System
- 510(k) Number
- FDA product code
- MNH
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AESUCLAP SOCON Spinal System is a spinal fixation device classified as a Spinal Fixation Device (Product Code: MNH). It is designed to stabilize the lumbar and sacral spine through pedicle screw fixation, facilitating surgical fusion in patients with severe spondylolisthesis at the L5-S1 vertebral joint. The system incorporates an autologous bone graft to promote bony union, with implants intended for temporary fixation until a solid fusion mass develops.
This system is supplied as a sterile, single-use device for orthopedic surgical applications. It is regulated under FDA 510(k) clearance (K970285) and is intended for use in controlled surgical environments. The device includes components for monosegmental and multisegmental fixation, with specific attention to MRI safety considerations as outlined in the manufacturer’s specifications. Proper storage and handling per instructions ensure sterility and functionality.
Other devices from Aesculap, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal conditions is the AESUCLAP SOCON Spinal System specifically designed to address in surgery?
The AESUCLAP SOCON Spinal System is designed to stabilize the lumbar and sacral spine, particularly for patients with severe spondylolisthesis at the L5-S1 vertebral joint. It facilitates surgical fusion by providing temporary fixation with pedicle screws and an autologous bone graft to promote bony union.
Is the AESUCLAP SOCON Spinal System intended for single-use or repeated use in surgery, and how is it supplied?
The system is supplied as a sterile, single-use device, meaning each set is intended for one surgical procedure. This ensures sterility and functionality while adhering to surgical best practices for implant safety.
What types of fixation configurations does the AESUCLAP SOCON Spinal System support, and how does this impact its versatility?
The system supports both monosegmental and multisegmental fixation, allowing surgeons to address varying degrees of spinal instability. This flexibility makes it adaptable to different patient anatomies and clinical needs during lumbar or sacral spine fusion procedures.
How should the AESUCLAP SOCON Spinal System be stored to maintain its integrity and sterility?
The device must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Proper storage conditions, such as avoiding contamination or exposure to extreme temperatures, are critical to ensure the implants remain ready for surgical use as intended.
Does the AESUCLAP SOCON Spinal System have any special considerations for MRI compatibility, and how should clinicians approach post-operative imaging?
The system includes MRI safety considerations as outlined in the manufacturer’s specifications. Clinicians should refer to these guidelines to determine whether and how post-operative MRI imaging can be safely performed, ensuring patient safety and diagnostic accuracy.