FortiShield (Biosynthetic Wound Matrix)
FDA 510(k) clearance K212579 · decided 2023-05-02
Clearance details
- K-number
- K212579
- Device name
- FortiShield (Biosynthetic Wound Matrix)
- Applicant
- Organogenesis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-16
- Decision date
- 2023-05-02
- Days to decision
- 624 days
- Clearance type
- Traditional
- Product code
- KGN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Canton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| APLIGRAF (P950032/S070) | Organogenesis, Inc. | 2014-03-10 |
| APLIGRAF (P950032/S074) | Organogenesis, Inc. | 2013-08-13 |
| APLIGRAF (P950032/S072) | Organogenesis, Inc. | 2013-07-11 |
| APLIGRAF (P950032/S073) | Organogenesis, Inc. | 2013-06-25 |
| APLIGRAF (P950032/S071) | Organogenesis, Inc. | 2013-03-14 |
| APLIGRAF (P950032/S069) | Organogenesis, Inc. | 2012-11-20 |
| APLIGRAF (P950032/S068) | Organogenesis, Inc. | 2012-04-03 |
| APLIGRAF (P950032/S067) | Organogenesis, Inc. | 2012-02-22 |