Cleared Special

MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR

K991528 · Danek Medical, Inc. · Orthopedic
May 1999
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K991528 is an FDA 510(k) clearance for the MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 28, 1999, 25 days after receiving the submission on May 3, 1999. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K991528 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1999
Decision Date May 28, 1999
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070