FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3DMatrix DynaFlex (DynaFlex)
K Number: K243302
·
Decision May 21, 2025
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
7
Applicant Total
2
Review Days
215
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Basic Information
- Device Name
- 3DMatrix DynaFlex (DynaFlex)
- K Number
- K243302
- 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
- October 18, 2024
- Decision Date
- May 21, 2025
- 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.
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Other Clearances by Printbio, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232602 | 3DMatrix Surgical Mesh | May 23, 2024 | Substantially Equivalent |