Cleared Traditional

SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM

K950099 · Buckman Co., Inc. · Orthopedic
Jan 1997
Decision
737d
Days
Class 2
Risk

About This 510(k) Submission

K950099 is an FDA 510(k) clearance for the SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on January 16, 1997, 737 days after receiving the submission on January 10, 1995. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K950099 FDA.gov
FDA Decision Cleared SN
Date Received January 10, 1995
Decision Date January 16, 1997
Days to Decision 737 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

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