WMT Implantable K-Wire
FDA 510(k) K132895 · Wrightmedicaltechnologyinc
510(k) numberK132895
Submission
- Device name
- WMT Implantable K-Wire
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- September 16, 2013
- Decision date
- October 23, 2013
- 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 |
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Questions and answers
When was WMT Implantable K-Wire cleared by the FDA?
WMT Implantable K-Wire (K132895) received a 510(k) decision of Substantially Equivalent on October 23, 2013, 37 days after the submission was received.
What is the product code of K132895?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.