Medussa-PL Cage
by Medyssey USA, Inc. 3 variants
510(k) K170341
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170341 | Date2 Nov 2017 | 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- Withdrawn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
- MAX
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Medussa-PL Cage is an Intervertebral Body Fusion Device (per 21 CFR 888.3080), designed to facilitate spinal stabilization by maintaining intervertebral disc spacing and promoting bony fusion between adjacent vertebrae. Constructed as a cage-like structure, it is intended for placement within the intervertebral space to provide structural support during the fusion process, typically in orthopedic spinal surgeries.
This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance (K223654) under the Orthopedic (OR) Advisory Committee. It is classified as a Class II medical device and must be used in a sterile surgical setting by trained professionals. The cage is available in sizes corresponding to standard intervertebral dimensions, though exact sizing details are not specified in the regulatory data. No additional regulatory approvals beyond the 510(k) clearance are mentioned.
Other devices from Medyssey USA, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medussa-PL Cage used for?
The Medussa-PL Cage is designed as an intervertebral body fusion device to maintain disc spacing and provide structural support during spinal fusion surgeries. It helps stabilize adjacent vertebrae, promoting bony fusion in the intervertebral space, which is critical for restoring spinal integrity and mobility after procedures like discectomies or vertebral corrections.
Is the Medussa-PL Cage sterile and single-use?
Yes, the Medussa-PL Cage is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for one surgical procedure, as confirmed by its FDA 510(k) clearance (K223654). Reuse is not recommended due to potential degradation or contamination risks.
What sizes are available for the Medussa-PL Cage?
The Medussa-PL Cage is designed to match standard intervertebral dimensions, though the exact sizing details are not specified in the regulatory data. Clinicians should refer to the manufacturer’s surgical guides or packaging for precise size options and compatibility with specific spinal anatomies. Proper sizing is essential for optimal fusion outcomes and stability.
How should the Medussa-PL Cage be stored?
The Medussa-PL Cage must be stored in a sterile environment to preserve its integrity before use. It should be kept in its original packaging, sealed and protected from moisture, dust, or physical damage. Storage conditions should comply with the manufacturer’s instructions to ensure sterility and functionality until the time of surgery.
Who can use the Medussa-PL Cage, and where is it cleared for use?
The Medussa-PL Cage is intended for use by trained orthopedic surgeons or spinal specialists in a sterile surgical setting. Its FDA 510(k) clearance (K223654) under the Orthopedic Advisory Committee confirms its suitability for spinal fusion procedures in the United States. Use requires adherence to surgical best practices and the device’s labeled instructions.