Identifiers
- 510(k) Number
- K020049 FDA 510(k)
- FDA Product Code
- FTM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Fortaflex Surgical Mesh is a surgical mesh device classified under regulation 878.3300. It is intended for implantation to reinforce soft tissue, including defects of the abdominal and thoracic wall, muscle flap reinforcement, and the reconstruction of rectal and vaginal prolapse.
This device is a Class II medical device that has received FDA 510(k) clearance. Specific details regarding sterility, storage, and single-use status are not provided in the available regulatory documentation.
Frequently asked questions
What is the primary clinical use for Fortaflex Surgical Mesh?
This device is intended for implantation to reinforce soft tissue. It is specifically indicated for the repair of abdominal and thoracic wall defects, muscle flap reinforcement, and the reconstruction of rectal and vaginal prolapse.
What is the regulatory classification of this device?
Fortaflex Surgical Mesh is classified as a Class II medical device under regulation 878.3300. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to a legally marketed predicate device.
Are there specific instructions for sterility or storage provided?
The available regulatory documentation for this device does not provide specific details regarding sterility, storage requirements, or whether the product is intended for single-use or reuse. Clinicians should consult the device labeling provided by Organogenesis Inc. for these handling instructions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FORTAFLEX SURGICAL MESH by ORGANOGENESIS, INC. | FDA 510 (k) Summary, FORTAFLEX SURGICAL MESH (K021105) — FDA 510 (k) | Innolitics, FORTAFLEX SURGICAL MESH (K020049) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020049 | Class II | Active |
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Manufacturer
- Manufacturer
- Organogenesis Inc.
- FDA Applicant
- Organogenesis, Inc.
Sources (1)
- FDA 510(k) K020049 24 fields · synced Sep 25, 2026