MTF Fascia
FDA 510(k) K120479 · Musculoskeletal Transplant Foundation
510(k) numberK120479
Submission
- Device name
- MTF Fascia
- Applicant
- Musculoskeletal Transplant Foundation
Washington, DC, US - Received
- February 16, 2012
- Decision date
- November 8, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- 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 tendon repair.
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| K251690 | Arthrex SpeedFLEX ImplantOWY · Traditional | Arthrex, Inc. | 09/30/2025SE |
| K252647 | Tapestry Biointegrative ImplantOWY · Special | Embody, Inc. | 09/19/2025SE |
| K250109 | TYBR Collagen GelOWY · Traditional | Tybr Health | 06/06/2025SE |
| K243843 | Tendon Protect (50242)OWY · Traditional | Kerecis Limited | 06/04/2025SE |
| K242631 | REGENETEN Bioinductive ImplantOWY · Traditional | Smith & Nephew Inc., Endoscopy Div. | 11/26/2024SE |
| K222501 | Regeneten Bioinductive ImplantOWY · Traditional | Smith and Nephew, Inc. | 05/11/2023SE |
| K220867 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 05/23/2022SE |
| K212306 | Tapestry Biointegrative ImplantOWY · Traditional | Embody, Inc. | 11/02/2021SE |
| K201572 | TAPESTRY Biointegrative ImplantOWY · Traditional | Embody, Inc. | 10/19/2020SE |
| K151083 | BioBridge Collagen MatrixOWY · Traditional | Fibralign Corporation | 01/08/2016SE |
More from Fibralign Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K181633 | MTF Pre-Sutured TendonGAT · Traditional | 03/15/2019SE |
| K121313 | MTF New Bone Void FillerMQV · Traditional | 01/11/2013SE |
| K113167 | MTF New Bone Voild FillerMQV · Traditional | 01/24/2012SE |
| K110003 | MTF New Bone Void FillerMQV · Traditional | 10/13/2011SE |
| K103795 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K103784 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 04/13/2011SE |
| K091217 | DBX Demineralized Bone Matrix PuttyNUN · Traditional | 10/02/2009SE |
| K091218 | DBX Demineralized Bone Matrix PuttyMQV · Traditional | 09/28/2009SE |
| K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMBP · Traditional | 10/10/2008SE |
| K080405 | Sygnal DBMMBP · Traditional | 08/28/2008SE |
Questions and answers
When was MTF Fascia cleared by the FDA?
MTF Fascia (K120479) received a 510(k) decision of Substantially Equivalent on November 8, 2012, 266 days after the submission was received.
What is the product code of K120479?
The FDA product code is OWY – Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon, a Class II (moderate risk) device regulated under 21 CFR 878.3300.