Cleared Traditional

SILMAX CONTOUR CARVING BLOCK IMPLANT

K002629 · Pillar Surgical, Inc. · Ear, Nose, Throat

Nov 2000

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K002629 is an FDA 510(k) clearance for the SILMAX CONTOUR CARVING BLOCK IMPLANT, a Polymer, Ent Synthetic, Porous Polyethylene (Class II — Special Controls, product code JOF), submitted by Pillar Surgical, Inc. (La Jolla, US). The FDA issued a Cleared decision on November 20, 2000, 89 days after receiving the submission on August 23, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K002629 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2000
Decision Date	November 20, 2000
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF