Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis
FDA 510(k) K133477 · Synchro Medical
510(k) numberK133477
Submission
- Device name
- Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis
- Applicant
- Synchro Medical
West Lawn, PA, US - Received
- November 12, 2013
- Decision date
- February 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K151241 | Synchro-Medical TIGER TRACK Screw SystemHWC · Traditional | 08/07/2015SE |
Questions and answers
When was Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis cleared by the FDA?
Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis (K133477) received a 510(k) decision of Substantially Equivalent on February 10, 2014, 90 days after the submission was received.
What is the product code of K133477?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.