PASS OCT Spinal System
by Medicrea International SA 3 variants
510(k) K150918
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150918 | Date16 Oct 2015 | 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- Withdrawn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
- NKG
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3075
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The PASS OCT Spinal System is a posterior cervical screw system (product code NKG) classified under Class II with special controls. It is designed to provide immobilization of spinal segments as an adjunct to spinal fusion, addressing acute and chronic instabilities in the craniocervical junction, cervical spine (C1–C7), and upper thoracic spine (T1–T3).
This system is intended for use in surgical settings and is supplied sterile for single-use. It is intended for immobilization of traumatic spinal fractures, dislocations, instability, or deformity. The device is authorized under FDA 510(k) clearance (K150918) and is manufactured by Medicrea International SA.
Other devices from Medicrea International SA
Questions
AI-generated answers, 20 Sep 2026
What specific spinal regions is the PASS OCT Spinal System designed to stabilize, and how does it differ from general cervical fixation systems?
The PASS OCT Spinal System is specifically designed to stabilize the craniocervical junction, cervical spine segments C1–C7, and the upper thoracic spine (T1–T3). Unlike general cervical fixation systems, it targets acute and chronic instabilities in these critical regions, including traumatic fractures, dislocations, instability, or deformity, making it suitable for complex cases requiring precise immobilization in these areas.
Is the PASS OCT Spinal System reusable, or is it intended for single-use only? How does this affect its handling and storage?
The PASS OCT Spinal System is supplied sterile and intended for single-use only. This means it must be handled with sterile techniques during surgery and discarded after use to maintain infection control. Storage should follow sterile packaging guidelines until the device is opened for surgical use, ensuring no contamination occurs before implantation.
What regulatory pathway was followed for FDA clearance of the PASS OCT Spinal System, and what does this mean for clinicians or hospitals considering its use?
The PASS OCT Spinal System received FDA clearance through a Traditional 510(k) pathway, classified under product code NKG (Class II with special controls). This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, meeting FDA’s requirements for safety and effectiveness. Clinicians or hospitals can rely on this clearance as evidence of regulatory scrutiny before adoption.
How is the PASS OCT Spinal System different from other posterior cervical screw systems, particularly in terms of its intended use?
While other posterior cervical screw systems may focus broadly on cervical spine stabilization, the PASS OCT Spinal System is explicitly designed for immobilization of the craniocervical junction, cervical spine (C1–C7), and upper thoracic spine (T1–T3). This broader scope includes addressing traumatic fractures, dislocations, instability, or deformity in these regions, making it suitable for complex cases where additional stability is required beyond standard cervical fixation.