3DMatrix Surgical Mesh
FDA 510(k) K232602 · Printbio, Inc.
510(k) numberK232602
Submission
- Device name
- 3DMatrix Surgical Mesh
- Applicant
- Printbio, Inc.
Long Island City, NY, US - Received
- August 28, 2023
- Decision date
- May 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXF – Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Other 510(k)s with product code OXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR)OXF · Traditional | Acera Surgical, Inc. | 06/20/2025SE |
| K243302 | 3DMatrix DynaFlex (DynaFlex)OXF · Traditional | Printbio, Inc. | 05/21/2025SE |
| K222919 | GORE® ENFORM BiomaterialOXF · Traditional | W. L. Gore and Associates, Inc. | 12/19/2022SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | W. L. Gore & Associates, Inc. | 04/05/2018SE |
| K172545 | SERI ContourOXF · Special | Sofregen Medical, Inc. | 09/22/2017SE |
| K163217 | GORE BIO-A Tissue ReinforcementOXF · Traditional | W. L. Gore & Associates, Inc. | 02/10/2017SE |
| K123128 | Seri Surgical ScaffoldOXF · Traditional | Allergan | 04/25/2013SE |
More from Allergan
| 510(k) | Device | Decision |
|---|---|---|
| K243302 | 3DMatrix DynaFlex (DynaFlex)OXF · Traditional | 05/21/2025SE |
Questions and answers
When was 3DMatrix Surgical Mesh cleared by the FDA?
3DMatrix Surgical Mesh (K232602) received a 510(k) decision of Substantially Equivalent on May 23, 2024, 269 days after the submission was received.
What is the product code of K232602?
The FDA product code is OXF – Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery, a Class II (moderate risk) device regulated under 21 CFR 878.3300.