Cleared Traditional

NEXA COMPRESSION SCREW

K060071 · Nexa Orthopedics, Inc. · Orthopedic
Jan 2006
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K060071 is an FDA 510(k) clearance for the NEXA COMPRESSION SCREW, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Nexa Orthopedics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 26, 2006, 17 days after receiving the submission on January 9, 2006. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K060071 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2006
Decision Date January 26, 2006
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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