Cleared Special

HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX

K102885 · Stryker Corp. · Orthopedic

Jan 2011

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K102885 is an FDA 510(k) clearance for the HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX, a Component, Traction, Invasive (Class II — Special Controls, product code JEC), submitted by Stryker Corp. (Malwah, US). The FDA issued a Cleared decision on January 14, 2011, 106 days after receiving the submission on September 30, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K102885 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2010
Decision Date	January 14, 2011
Days to Decision	106 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF