Cleared Traditional

K911306 - T-BOLT AND NUT
(FDA 510(k) Clearance)

K911306 · Danek Medical, Inc. · Orthopedic

Sep 1991

Decision

169d

Days

Class 2

Risk

K911306 is an FDA 510(k) clearance for the T-BOLT AND NUT. This device is classified as a Washer, Bolt Nut (Class II — Special Controls, product code HTN).

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 10, 1991, 169 days after receiving the submission on March 25, 1991.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K911306 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1991
Decision Date	September 10, 1991
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—