S128 Anterior Lumbar Interbody Fusion System
by Renovis Surgical Technologies, Inc. 2 variants
510(k) K180502
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180502 | Date14 Jun 2018 | 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- Withdrawn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
- S128 Anterior Lumbar Interbody Fusion (ALIF) System
- 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, 1 Oct 2026
The S128 Anterior Lumbar Interbody Fusion System is a spinal implant designed for intervertebral body fusion. It consists of cages, bone screws, and an anterior cover plate assembly intended to stabilize and promote bony fusion in the lumbar spine. This device is classified under the FDA’s Orthopedic category (product code OVD) and is intended for use in skeletally mature patients. The system facilitates structural support and alignment during spinal fusion procedures.
The system is supplied sterile and intended for single-use. It is cleared for use in anterior lumbar interbody fusion procedures at one or two contiguous levels from L2 to S1. The device requires surgical implantation and is regulated under FDA’s 510(k) clearance (K180502) via a traditional review pathway. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Other devices from Renovis Surgical Technologies
Questions
AI-generated answers, 1 Oct 2026
What is the S128 Anterior Lumbar Interbody Fusion System used for?
The S128 ALIF System is designed for anterior lumbar interbody fusion procedures. It provides structural support and alignment during spinal fusion at one or two contiguous lumbar levels (L2 to S1) to promote bony fusion in skeletally mature patients. The system consists of cages, bone screws, and an anterior cover plate assembly to facilitate stabilization.
How is the S128 ALIF System supplied and what are its sterility and reuse details?
The S128 ALIF System is supplied sterile and is intended for single-use only. This ensures patient safety and maintains device integrity, as reuse could compromise sterility and performance. Always follow sterile medical device handling protocols before use.
What levels of the lumbar spine can the S128 ALIF System be used for?
The system is cleared for use at one or two contiguous lumbar levels, specifically from L2 through S1. This range allows surgeons to address various spinal pathologies requiring anterior interbody fusion in the lower lumbar region.
How should the S128 ALIF System be stored to maintain sterility?
The system must be stored in accordance with sterile medical device protocols to preserve its integrity. This includes keeping it in its original packaging, away from moisture, extreme temperatures, and contamination until immediate preoperative use. Always check expiration dates and storage conditions as indicated on the packaging.
What regulatory pathway was used for FDA clearance of the S128 ALIF System?
The S128 ALIF System received FDA clearance through the traditional 510(k) review pathway, specifically under clearance number K180502. The device was determined to be substantially equivalent to a legally marketed predicate device and falls under the Orthopedic category (product code OVD).