Cleared Traditional

BONE BAND

K983685 · Chapel and Assoc. · Orthopedic

Dec 1998

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K983685 is an FDA 510(k) clearance for the BONE BAND, a Fixation Accessory (Class II — Special Controls, product code LYT), submitted by Chapel and Assoc. (Denton, US). The FDA issued a Cleared decision on December 4, 1998, 45 days after receiving the submission on October 20, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K983685 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1998
Decision Date	December 04, 1998
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF