Cleared Traditional

K870668 - DRIVER-BENDER-EXTRACTOR, BONE PIN
(FDA 510(k) Clearance)

Mar 1987
Decision
18d
Days
Class 1
Risk

K870668 is an FDA 510(k) clearance for the DRIVER-BENDER-EXTRACTOR, BONE PIN. This device is classified as a Bender (Class I - General Controls, product code HXW).

Submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 9, 1987, 18 days after receiving the submission on February 19, 1987.

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

Submission Details

510(k) Number K870668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date March 09, 1987
Days to Decision 18 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