Mecta-C Stand Alone Extension

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K203076 ↗

FDA Product Code

OVE

Device Class

Class II

Regulation

21 CFR Part 888.3080

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Medacta International S.A. →

• What types of spinal procedures is the Mecta-C Stand Alone Extension designed to support, and how does its modular design benefit the surgeon?

  The Mecta-C Stand Alone Extension is specifically designed for lumbar or cervical interbody fusion procedures, providing structural support to stabilize the spine and promote bony fusion between vertebrae. Its modular design offers eight configurable implant options, allowing surgeons to select the best fit for individual anatomical needs, ensuring a tailored approach to spinal stabilization.

• Is the Mecta-C Stand Alone Extension reusable, or is it intended for single-use only? How should it be handled to maintain sterility?

  The Mecta-C Stand Alone Extension is intended for single-use only and is supplied sterile. To preserve sterility before surgical use, it must be stored and handled according to standard sterile medical device protocols, ensuring its integrity remains uncompromised until implantation.

• What regulatory pathway was followed for FDA clearance of this device, and what does the ‘substantially equivalent’ designation mean in this context?

  The Mecta-C Stand Alone Extension received FDA 510(k) clearance (K203076) under a *Special* clearance type, classified under the *Orthopedic* advisory committee (OR). The ‘substantially equivalent’ designation (decision_code: SESE) means the FDA determined it is as safe and effective as a legally marketed device that served as its predicate, without requiring third-party review.

• How should the device be stored, and are there any specific instructions related to its packaging or shelf life?

  While the provided data does not specify shelf life, the device must be stored and handled in compliance with sterile medical device protocols to maintain its integrity. The sterile packaging should remain unopened until immediate preoperative use, and any storage conditions should align with manufacturer-recommended practices for orthopedic implants.