Mendec Spine
510(k) K042415
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042415 | Date9 Jun 2005 | 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- Withdrawn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
- NDN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3027
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Mendec Spine is a Cement, Bone, Vertebroplasty device, designed for vertebral augmentation procedures. It delivers bone cement to stabilise fractured or compromised vertebrae, restoring structural integrity and alleviating pain in orthopaedic applications.
This device is supplied as a closed-system kit, combining resin and delivery components for sterile, single-use application. It requires no external accessories beyond the included Mendec Spine Gun for injection. Authorised under FDA 510K clearance (K042415), it adheres to Class II regulatory standards for orthopaedic bone cement systems.
From the manufacturer
Mendec ® Spine Kit è il kit completo per le procedure di Vertebral Augmentation, e non richiede alcun accessorio esterno per la preparazione e la delivery della resina.
Other devices from Tecres S.p.A.
Questions
AI-generated answers, 19 Sep 2026
What is the Mendec Spine used for in clinical practice?
The Mendec Spine is designed for vertebral augmentation procedures, specifically to deliver bone cement into fractured or compromised vertebrae. This stabilizes the spine, restores structural integrity, and helps alleviate pain in orthopedic applications, particularly for patients with vertebral instability or compression fractures.
Is the Mendec Spine kit sterile and intended for single-use only?
Yes, the Mendec Spine is supplied as a closed-system kit that is sterile and intended for single-use only. This ensures safety and consistency in clinical procedures, as it combines resin and delivery components without requiring additional external accessories beyond the included Mendec Spine Gun.
How is the Mendec Spine regulated, and what does that mean for its use?
The Mendec Spine is authorized under FDA 510K clearance (K042415) and classified as a Class II medical device. This means it has undergone a regulatory review process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for vertebral augmentation procedures in orthopedic applications.
Are there different sizes or models of the Mendec Spine available?
The provided data does not specify individual sizes or models of the Mendec Spine kit. However, it is supplied as a closed-system kit, implying it may include components tailored for various clinical scenarios. For precise sizing or model details, refer to the manufacturer’s technical documentation or consult Tecres S.p.A. directly.
What accessories are required to use the Mendec Spine, and how is it administered?
The Mendec Spine kit includes all necessary components for use, including the Mendec Spine Gun for injection. No additional external accessories are required beyond what is provided in the kit. The device is administered by delivering bone cement directly into the compromised vertebra to stabilize it and relieve pain.