SPEED XL

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K133780 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K971782 Active Cleared 29 Jul 1997

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  FDA 510(k) K102107 Active Cleared 3 Sep 2010

• Memograph; Osstaple - Oral and Maxilliofacial Procedures for the Memograph Staple System

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• Bme Bone Drill Bits

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  FDA 510(k) K964073 Active Cleared 14 Nov 1996

See all devices from Biomedical Ent., Inc. →

• What is the SPEED XL used for?

  The SPEED XL is an orthopedic device designed specifically for use in surgical procedures. It is manufactured by Biomedical Ent., Inc. and has received FDA 510K clearance for its intended application in orthopedic surgeries.

• In what sizes is the SPEED XL available?

  The SPEED XL is available in various sizes to accommodate different surgical needs and patient anatomies. The specific size options should be selected according to the surgical requirements and manufacturer recommendations.

• How should the SPEED XL be stored?

  The SPEED XL should be stored according to the manufacturer's instructions to maintain its integrity and functionality. Proper storage conditions are essential to ensure the device remains in optimal condition for surgical use.

• What is the regulatory status of the SPEED XL?

  The SPEED XL has FDA 510K clearance with the decision code SESE (Substantially Equivalent) and was reviewed by the Orthopedic advisory committee. It received clearance on March 19, 2014, with K-number K133780.