Cleared Traditional

K872949 - ACROMED BONE PLATE BENDER (FDA 510(k) Clearance)

Oct 1987
Decision
79d
Days
Class 1
Risk

K872949 is an FDA 510(k) clearance for the ACROMED BONE PLATE BENDER. This device is classified as a Bender (Class I - General Controls, product code HXW).

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on October 15, 1987, 79 days after receiving the submission on July 28, 1987.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K872949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1987
Decision Date October 15, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary

Device Classification

Product Code HXW — Bender
Device Class Class I - General Controls
CFR Regulation 21 CFR 888.4540