510(k) K251690
- Device
- Arthrex SpeedFLEX Implant
- Applicant
- Arthrex, Inc.
- 510(k) number
- K251690
- Product code
- OWY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-30
- Date received
- 2025-06-02
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Emmarie Halteman
- Address
- 1370 Creekside Blvd. Naples FL US 34108 34108
FDA Registration Numbers
- 1450662
- 3015724777
- 3003604053
- 3008868758
- 2245304
- 3012358417
- 2249852
- 3027448274
- 3013037653
- 3010331645
- 1220246
- 3004464325
- 3012448339
- 3010600625
- 2530154
- 3015231789
- 3005381997
- 3010400367
- 1226146
- 1017294
- 3010273872
- 1047843
- 3019101334
- 3016429246
- 2246552
- 1319660
- 3009882464
- 3015543569
- 3027383505
- 1320894
- 1064858
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code OWY
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252647 | Tapestry Biointegrative Implant | Embody, Inc. | 2025-09-19 |
| K250109 | TYBR Collagen Gel | Tybr Health | 2025-06-06 |
| K243843 | Tendon Protect (50242) | Kerecis Limited | 2025-06-04 |
| K242631 | REGENETEN Bioinductive Implant | Smith & Nephew Inc., Endoscopy Div. | 2024-11-26 |
| K222501 | Regeneten Bioinductive Implant | Smith and Nephew, Inc. | 2023-05-11 |
| K220867 | Tapestry Biointegrative Implant | Embody, Inc. | 2022-05-23 |
| K212306 | Tapestry Biointegrative Implant | Embody, Inc. | 2021-11-02 |
| K201572 | TAPESTRY Biointegrative Implant | Embody, Inc. | 2020-10-19 |
| K151083 | BioBridge Collagen Matrix | Fibralign Corporation | 2016-01-08 |
| K140300 | COLLAGEN TENDON SHEET-DDI (CTS-DDI) | Rotation Medical, Inc. | 2014-03-26 |
| K133169 | MESO TENDON MATRIX | Kensey Nash Corporation Dba Dsm Biomedical | 2013-12-20 |
| K131143 | TRELLIS COLLAGEN RIBBON | Wrightmedicaltechnologyinc | 2013-10-07 |
| K120479 | MTF FASCIA | Musculoskeletal Transplant Foundation | 2012-11-08 |