510(k) K243302
- Device
- 3DMatrix DynaFlex (DynaFlex)
- Applicant
- Printbio, Inc.
- 510(k) number
- K243302
- Product code
- OXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-21
- Date received
- 2024-10-18
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Janet Vargo
- Address
- 51-36 35th St. Long Island City NY US 11101 11101
FDA Registration Numbers#
- 3002719998
- 3006017180
- 3002924436
- 3012429393
- 3003910212
- 3004681519
- 1319639
Source Documents#
Other 510(k) Records For Product Code OXF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025-06-20 |
| K232602 | 3DMatrix Surgical Mesh | Printbio, Inc. | 2024-05-23 |
| K222919 | GORE® ENFORM Biomaterial | W. L. Gore and Associates, Inc. | 2022-12-19 |
| K173333 | GORE ENFORM Biomaterial | W. L. Gore & Associates, Inc. | 2018-04-05 |
| K172545 | SERI Contour | Sofregen Medical, Inc. | 2017-09-22 |
| K163217 | GORE BIO-A Tissue Reinforcement | W. L. Gore & Associates, Inc. | 2017-02-10 |
| K123128 | SERI SURGICAL SCAFFOLD | Allergan | 2013-04-25 |