Cleared Traditional

K810557 - HIP ABDUCTION SPLINT
(FDA 510(k) Clearance)

K810557 · Orthomedics · Physical Medicine device

Mar 1981

Decision

11d

Days

Class 1

Risk

K810557 is an FDA 510(k) clearance for the HIP ABDUCTION SPLINT. This device is classified as a Splint, Abduction, Congenital Hip Dislocation (Class I - General Controls, product code IOZ).

Submitted by Orthomedics (Mchenry, US). The FDA issued a Cleared decision on March 13, 1981, 11 days after receiving the submission on March 2, 1981.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3665.

Submission Details

510(k) Number	K810557 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 1981
Decision Date	March 13, 1981
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—