Cleared Traditional

K770900 - CAST BRWM, FRACTURE
(FDA 510(k) Clearance)

K770900 · Chase Mfg. Co. · Physical Medicine device

Jul 1977

Decision

66d

Days

Class 1

Risk

K770900 is an FDA 510(k) clearance for the CAST BRWM, FRACTURE. This device is classified as a Cage, Knee (Class I - General Controls, product code ITM).

Submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977, 66 days after receiving the submission on May 16, 1977.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number	K770900 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 16, 1977
Decision Date	July 21, 1977
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—