Cleared Traditional

ASCENSION PYROCARBON LUNATE

K080997 · Ascension Orthopedics, Inc. · Orthopedic
Jun 2008
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K080997 is an FDA 510(k) clearance for the ASCENSION PYROCARBON LUNATE, a Prosthesis, Wrist, Carpal Lunate (Class II — Special Controls, product code KWN), submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 17, 2008, 70 days after receiving the submission on April 8, 2008. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3750.

Submission Details

510(k) Number K080997 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2008
Decision Date June 17, 2008
Days to Decision 70 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWN — Prosthesis, Wrist, Carpal Lunate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3750