Reef L Interbody System; WaveForm L Interbody System
by SeaSpine Orthopedics Corporation
510(k) K240566
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240566 | Date26 Apr 2024 | 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- Withdrawn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
- Models / Variants
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Reef L Interbody System and WaveForm L Interbody System are spinal interbody devices designed for lumbar interbody fusion. These implants are intended to provide structural support and promote spinal stability in skeletally mature patients undergoing spinal fusion surgery, particularly for degenerative disc disease with discogenic back pain.
These systems are supplied as single-use, sterile implants and are regulated under FDA 510(k) clearance (K240566) as substantially equivalent to predicate devices. They are classified under FDA product code MAX and are intended for use in orthopedic spinal procedures, adhering to standard surgical sterility and handling protocols. No additional regulatory markings or MRI safety classifications are specified.
Other devices from SeaSpine Orthopedics Corporation
Questions
AI-generated answers, 19 Sep 2026
Are the Reef L and WaveForm L Interbody Systems reusable or single-use, and how should they be handled during surgery?
Both the Reef L and WaveForm L Interbody Systems are designed as single-use implants. Since they are sterile upon packaging, they must be handled according to standard surgical sterility protocols to avoid contamination. Once used, they should not be reused, as this could compromise patient safety and device integrity.
What types of lumbar spinal conditions are these devices intended to address, and who is the typical patient population?
These systems are intended for skeletally mature patients undergoing lumbar interbody fusion surgery, specifically for degenerative disc disease with discogenic back pain. They provide structural support and promote spinal stability in the lumbar region, helping restore alignment and facilitate fusion.
How are these devices regulated in the U.S., and what does the FDA’s clearance mean for their use?
The Reef L and WaveForm L Interbody Systems are regulated under FDA 510(k) clearance (K240566), meaning they are deemed substantially equivalent to a predicate device already on the market. This clearance confirms they meet FDA safety and effectiveness standards for spinal interbody fusion procedures, but it does not imply approval for any specific clinical indication beyond what is stated in the device description.
Are there different sizes or models available for these systems, and how might a surgeon choose between them?
While the provided data does not specify exact sizing details, the Reef L and WaveForm L systems are designed as lumbar interbody implants, implying they come in a range of sizes to accommodate varying patient anatomies. Surgeons typically select based on patient anatomy, spinal level, and fusion requirements, often using intraoperative imaging or templating tools to match the implant dimensions to the target disc space.