Cleared Traditional

K882967 - BONE FIXATION WIRE (FDA 510(k) Clearance)

K882967 · Baxter Healthcare Corp · Orthopedic device

Sep 1988

Decision

77d

Days

Class 2

Risk

K882967 is an FDA 510(k) clearance for the BONE FIXATION WIRE. This device is classified as a Cerclage, Fixation (Class II - Special Controls, product code JDQ).

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on September 30, 1988, 77 days after receiving the submission on July 15, 1988.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K882967 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 15, 1988
Decision Date	September 30, 1988
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—