Cleared Traditional

CERAMIC TIPPED SKULL PIN

K040363 · The Jerome Group, Inc. · Orthopedic

Apr 2004

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K040363 is an FDA 510(k) clearance for the CERAMIC TIPPED SKULL PIN, a Fixation Accessory (Class II — Special Controls, product code LYT), submitted by The Jerome Group, Inc. (Moorestown, US). The FDA issued a Cleared decision on April 12, 2004, 59 days after receiving the submission on February 13, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K040363 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2004
Decision Date	April 12, 2004
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF