Cleared Traditional

K021782 - BNF (FDA 510(k) Clearance)

K021782 · Aap Implantate AG · Orthopedic device

Aug 2002

Decision

88d

Days

Class 2

Risk

K021782 is an FDA 510(k) clearance for the BNF. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).

Submitted by Aap Implantate AG (Berlin, DE). The FDA issued a Cleared decision on August 26, 2002, 88 days after receiving the submission on May 30, 2002.

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

Submission Details

510(k) Number	K021782 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 30, 2002
Decision Date	August 26, 2002
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF