Seidel Humeral Locking Nail -- Additional Lengths
by Howmedica Corp. 510(k)
Active
510(k) K924004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK924004 | Date23 Nov 1992 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JDS
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Seidel Humeral Locking Nail — Additional Lengths is a bone fixation device classified as a Nail, Fixation, Bone. It is designed for internal fixation of humeral fractures, providing stable alignment and mechanical support through interlocking screws and a locking mechanism to secure the nail within the medullary cavity of the humerus.
This device is supplied in multiple lengths and is intended for use in orthopedic surgical settings. It is classified as a Class II medical device under FDA regulations and received 510(k) clearance (K924004) in 1992. The nail is reusable and requires sterile packaging for surgical use. No MRI safety information or single-use designation is specified in the available data.
Other devices from Howmedica Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the Seidel Humeral Locking Nail — Additional Lengths used for?
This device is designed for internal fixation of humeral fractures. It provides stable alignment and mechanical support by securing a nail within the medullary cavity of the humerus, reinforced with interlocking screws. This ensures proper bone healing and reduces displacement during recovery.
How is the Seidel Humeral Locking Nail — Additional Lengths supplied?
The nail is available in multiple lengths to accommodate different patient anatomies and fracture types. It is packaged sterilely for surgical use, ensuring readiness for immediate application in orthopedic procedures.
Is the Seidel Humeral Locking Nail — Additional Lengths single-use or reusable?
This device is classified as reusable. However, it must be sterilized between uses to maintain safety and efficacy. Sterile packaging is provided for surgical applications, but reprocessing protocols must be followed for reuse.
What lengths are available for the Seidel Humeral Locking Nail — Additional Lengths?
The device is offered in a variety of lengths, as indicated by the extensive list of FEI numbers (e.g., 3002806685, 3016438694, etc.). These lengths cater to different humeral bone sizes and fracture patterns, ensuring compatibility with diverse clinical cases.
How should the Seidel Humeral Locking Nail — Additional Lengths be stored?
The nail should be stored in its original sterile packaging until ready for use. If reused, it must undergo proper sterilization procedures between cases to prevent contamination. Always follow manufacturer guidelines for storage and reprocessing to ensure device integrity and patient safety.