Cleared Traditional

LUNDEEN SUBTALAR PEG IMPLANT

K922292 · Sgarlato Laboratories, Inc. · Orthopedic

Oct 1992

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K922292 is an FDA 510(k) clearance for the LUNDEEN SUBTALAR PEG IMPLANT, a Prosthesis, Subtalar, Plug, Polymer (Class II — Special Controls, product code MJW), submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on October 23, 1992, 161 days after receiving the submission on May 15, 1992. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K922292 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 1992
Decision Date	October 23, 1992
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement