SPEED ARC
FDA 510(k) clearance K133270 · decided 2014-04-17
Clearance details
- K-number
- K133270
- Device name
- SPEED ARC
- Applicant
- Biomedical Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-23
- Decision date
- 2014-04-17
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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| TMC Compression Implant System (K242415) | Treace Medical Concepts | 2024-09-06 |
| COGNiTiON™ Staple System (K240212) | Ortho Solutions UK , Ltd. | 2024-02-23 |
| A’TOMIC™ Nitinol Fixation System (K232990) | Rmr Ortho, LLC | 2024-01-12 |
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| Medline UNITE® REFLEX® Nitinol Staple Kit (K232905) | Medline Industries, LP | 2023-10-19 |
| StealthFix Intraosseous Fixation System (K232324) | Medartis, Inc. | 2023-08-30 |
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Recalls involving this device
No recalls on record reference this clearance.