Rodriguez Nail

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871608 ↗

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) K842475 Active Cleared 17 Sep 1984

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• U-Impulse Air Conduction in-the-Canal Hearing Aid

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• Omni Itc Type Hearing Aid Model U-Impulse Sp

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• Tricon-M Total Knee System

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  FDA 510(k) K884824 Active Cleared 21 Nov 1989

• Orthopaedic Cable System

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  FDA 510(k) K842977 Active Cleared 26 Oct 1984

See all devices from Richards Medical Co., Inc. →

• What is the Rodriguez Nail used for?

  The Rodriguez Nail is an orthopedic device classified under product code HSB, indicating its use in orthopedic applications. It is intended for orthopedic use as a Class II medical device, based on its classification and clearance details.

• How was the Rodriguez Nail cleared for market?

  The Rodriguez Nail received FDA 510(k) clearance through the traditional pathway, determined to be substantially equivalent to a predicate device. Clearance was granted on May 8, 1987, following submission on April 24, 1987, under k-number K871608.

• Who manufactures the Rodriguez Nail and where are they located?

  The Rodriguez Nail is manufactured by Richards Medical Co., Inc., located at 1450 Brooks Rd., Memphis, TN 38116, United States. The applicant and manufacturer are the same entity, as listed in the device authorization data.

• What regulatory class and product code does the Rodriguez Nail have?

  The Rodriguez Nail is regulated as a Class II medical device and is classified under product code HSB, which corresponds to the orthopedic advisory committee designation (OR). This classification reflects its regulatory pathway and intended use domain.