Extremity Medical Hammertoe Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K133636 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Extremity Medical Hammertoe Device is an orthopedic implant indicated for osteotomy fixation and reconstruction of the lesser toes following correctional procedures for hammertoe, claw toe, and mallet toe. The device is available in three size options and is designed to enhance patient outcomes in extremity surgery.
The device is supplied as a sterile, single-use implant and is intended for use in orthopedic procedures. It has FDA 510(k) clearance with the product code HWC and is manufactured by Extremity Medical, LLC. The device should be stored according to the manufacturer's instructions and is not intended for MRI environments.
Frequently asked questions
What is the Extremity Medical Hammertoe Device used for?
The Extremity Medical Hammertoe Device is an orthopedic implant indicated for osteotomy fixation and reconstruction of the lesser toes following correctional procedures for hammertoe, claw toe, and mallet toe conditions.
How is the Extremity Medical Hammertoe Device supplied?
The device is supplied as a sterile, single-use implant intended for orthopedic procedures. It is available in three size options to accommodate different patient needs and surgical requirements.
What is the regulatory status of the Extremity Medical Hammertoe Device?
The device has FDA 510(k) clearance with the product code HWC. It received clearance through the traditional pathway with a decision code of SESE (Substantially Equivalent) on March 28, 2014.
How should the Extremity Medical Hammertoe Device be stored?
The device should be stored according to the manufacturer's instructions. It is important to note that the device is not intended for use in MRI environments, so proper storage conditions should exclude such environments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hammertoe Correction | Extremity Medical, HammerFiX - Extremity Medical, K133636 FDA 510 (k) - EXTREMITY MEDICAL HAMMERTOE DEVICE, EXTREMITY MEDICAL HAMMERTOE DEVICE (K133636) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133636 | Class II | Active |
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Manufacturer
- Manufacturer
- Extremity Medical, LLC
Sources (1)
- FDA 510(k) K133636 24 fields · synced Oct 1, 2026