Seidel Humeral Locking Nail

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931256 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

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  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the Seidel Humeral Locking Nail used for?

  The Seidel Humeral Locking Nail is a rod fixation device designed for intramedullary use in the humerus. It provides stabilization for fractures of the humeral shaft, helping to properly align and secure the bone during healing.

• Is the Seidel Humeral Locking Nail reusable or single-use?

  The Seidel Humeral Locking Nail is supplied as a single-use implant. It is not designed to be reused, and each device should be discarded after a single surgical procedure to ensure patient safety and device integrity.

• What are the regulatory approvals for the Seidel Humeral Locking Nail?

  The Seidel Humeral Locking Nail is classified under product code HSB as a Class II device with special controls. It received FDA 510(k) clearance on July 2, 1993, with the K number K931256, making it substantially equivalent to predicate devices.

• Is the Seidel Humeral Locking Nail MRI compatible?

  No, the Seidel Humeral Locking Nail is not MRI compatible. Patients with this implant should avoid MRI scans as the device may interfere with the imaging process and potentially cause artifacts or safety concerns.