Cleared Traditional

LESSER METATARSAL PHALANGEAL JOINT IMPLANT

K023531 · Nexa Orthopedics, Inc. · Orthopedic
Jan 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K023531 is an FDA 510(k) clearance for the LESSER METATARSAL PHALANGEAL JOINT IMPLANT, a Prosthesis, Toe, Constrained, Polymer (Class II — Special Controls, product code KWH), submitted by Nexa Orthopedics, Inc. (Vista, US). The FDA issued a Cleared decision on January 17, 2003, 88 days after receiving the submission on October 21, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3720.

Submission Details

510(k) Number K023531 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2002
Decision Date January 17, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWH — Prosthesis, Toe, Constrained, Polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3720