Cleared Traditional

SPEED XL

K133780 · Biomedical Ent., Inc. · Orthopedic
Mar 2014
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K133780 is an FDA 510(k) clearance for the SPEED XL, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 19, 2014, 97 days after receiving the submission on December 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K133780 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2013
Decision Date March 19, 2014
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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