ProLift Lateral Fixated
510(k) K200338
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200338 | Date17 Apr 2020 | 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- Withdrawn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
- OVD
- 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 ProLift Lateral Fixated is a lateral lumbar interbody fusion device designed for spinal reconstruction. It features Osseo-Loc Surface Technology and provides up to 6mm of in situ expansion with adjustable lordosis of up to 15°, enabling disc height restoration and neural decompression.
This device is intended for micro-invasive lateral lumbar procedures and is supplied in various starting heights to maximize endplate coverage. It is a reusable orthopedic implant cleared under FDA 510(k) (K200338) for traditional review in the Orthopedic category, with no third-party involvement. Sterility, MRI safety, and single-use status are not specified in the provided data.
Other devices from Life Spine, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal procedures is the ProLift Lateral Fixated designed for, and how does its design support those procedures?
The ProLift Lateral Fixated is specifically designed for micro-invasive lateral lumbar interbody fusion procedures. Its Osseo-Loc Surface Technology enhances bone integration, while its expandable design (up to 6mm in situ expansion) and adjustable lordosis (up to 15°) allow for precise disc height restoration and neural decompression, which are critical for stabilizing the spine and relieving pressure on nerves during these minimally invasive surgeries.
How is the ProLift Lateral Fixated supplied, and what starting heights are available to ensure proper endplate coverage?
The ProLift Lateral Fixated is supplied in multiple starting heights to maximize endplate coverage during lateral lumbar procedures. While exact sizes aren’t detailed, the adjustable expansion feature (up to 6mm) ensures adaptability to varying anatomical needs, helping surgeons achieve optimal fit and stability during implantation.
Is the ProLift Lateral Fixated reusable, and if so, what considerations should be made during its use?
The provided data does not specify whether the ProLift Lateral Fixated is single-use or reusable. However, since it is classified as an orthopedic implant and lacks explicit sterility or reuse instructions, users should follow manufacturer guidelines (Life Spine, Inc.) for reprocessing if intended for reuse, including cleaning, sterilization, and inspection protocols to ensure safety and performance.
What regulatory pathway was followed for FDA clearance of the ProLift Lateral Fixated, and what does that mean for its use?
The ProLift Lateral Fixated received FDA 510(k) clearance (K200338) under the Traditional Review pathway in the Orthopedic category (product code OVD). This means it was determined to be substantially equivalent to a legally marketed device, ensuring compliance with FDA standards for safety and effectiveness. Clinicians and buyers can rely on this clearance as confirmation of its regulatory validation for lateral lumbar fusion procedures.