Mantis Spinal System
510(k) K073151
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073151 | Date6 Dec 2007 | 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- Withdrawn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
- NKB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mantis Spinal System is a spinal fixation device designed for orthopedic applications, classified under the product code NKB. It features cannulated screws, including standard and reduction variants, to provide stabilization for spinal procedures. The system is engineered to complement existing spinal constructs, offering modular solutions for surgical interventions.
This system is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance under Special review (K073151). It is intended for use in orthopedic settings, where spinal stabilization is required. The device is manufactured by Stryker Corp. and must be stored according to manufacturer instructions to maintain sterility and performance. No additional regulatory markings beyond the FDA clearance are stated.
Other devices from Stryker Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Mantis Spinal System used for?
The Mantis Spinal System is a spinal fixation device intended for orthopedic applications, specifically to provide stabilization during spinal procedures. It features cannulated screws—including standard and reduction variants—to complement existing spinal constructs, offering modular solutions for surgical interventions. This system is engineered to enhance surgical outcomes by ensuring secure fixation in spinal surgeries.
How is the Mantis Spinal System supplied and intended for use?
The Mantis Spinal System is supplied sterile and is intended for single-use only. This ensures optimal safety and performance during surgical procedures. The device adheres to FDA 510(k) clearance under Special Review (K073151), confirming its regulatory compliance for use in orthopedic settings where spinal stabilization is required.
Are there different sizes or models available in the Mantis Spinal System?
The Mantis Spinal System includes cannulated screws in two primary variants: standard and reduction screws. These variants are designed to accommodate different surgical needs and construct requirements, allowing for flexibility in spinal fixation applications. The system’s modular design ensures compatibility with existing spinal constructs.
How should the Mantis Spinal System be stored to maintain sterility?
To maintain sterility and performance, the Mantis Spinal System must be stored strictly according to the manufacturer’s instructions provided by Stryker Corp. Improper storage could compromise the device’s integrity, so adherence to these guidelines is critical for ensuring safe and effective use during surgery.
What regulatory approval does the Mantis Spinal System hold?
The Mantis Spinal System holds FDA 510(k) clearance under Special Review (K073151), confirming it is deemed substantially equivalent to a legally marketed predicate device. This clearance is specific to its intended use in spinal stabilization procedures and does not imply broader regulatory markings beyond what is stated.