FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3DMatrix Surgical Mesh
K Number: K232602
·
Decision May 23, 2024
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
2
Review Days
269
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Basic Information
- Device Name
- 3DMatrix Surgical Mesh
- K Number
- K232602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Printbio, Inc.
- Date Received
- August 28, 2023
- Decision Date
- May 23, 2024
- Product Code
- OXF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OXF), ordered by most recent decision date.
Restrata Soft Tissue Reinforcement (STR)
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3DMatrix DynaFlex (DynaFlex)
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GORE® ENFORM Biomaterial
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SERI Contour
FDA 510(k)
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GORE BIO-A Tissue Reinforcement
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Printbio, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243302 | 3DMatrix DynaFlex (DynaFlex) | May 21, 2025 | Substantially Equivalent |