A.M. Surgical Intramedullary Fixation Device
FDA 510(k) K180087 · A.M. Surgical, Inc.
510(k) numberK180087
Submission
- Device name
- A.M. Surgical Intramedullary Fixation Device
- Applicant
- A.M. Surgical, Inc.
Smithtown, NY, US - Received
- January 12, 2018
- Decision date
- May 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K191771 | SECURE ScrewHWC · Traditional | 10/16/2019SE |
| K191345 | Pegasus SystemHRX · Traditional | 07/17/2019SE |
| K080133 | Mountable Endoscopic BladeEMF · Traditional | 03/13/2008SE |
| K042458 | A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemLXT · Traditional | 10/07/2004SE |
| K982142 | Mountable Endoscopic KnifeEMF · Traditional | 12/30/1998SE |
Questions and answers
When was A.M. Surgical Intramedullary Fixation Device cleared by the FDA?
A.M. Surgical Intramedullary Fixation Device (K180087) received a 510(k) decision of Substantially Equivalent on May 18, 2018, 126 days after the submission was received.
What is the product code of K180087?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.