Cleared Traditional

K831898 - SCOLIMETER
(FDA 510(k) Clearance)

K831898 · Dr. Micheal A. Sabia · Orthopedic device

Jul 1983

Decision

35d

Days

Class 1

Risk

K831898 is an FDA 510(k) clearance for the SCOLIMETER. This device is classified as a Caliper (Class I - General Controls, product code KTZ).

Submitted by Dr. Micheal A. Sabia (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 35 days after receiving the submission on June 14, 1983.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4150.

Submission Details

510(k) Number	K831898 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 1983
Decision Date	July 19, 1983
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—