Cleared Traditional

K970040 - SPINE-TECH BONE HARVESTER (FDA 510(k) Clearance)

Class I Orthopedic device.

K970040 · Spine-Tech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
53d
Days
Class 1
Risk

K970040 is an FDA 510(k) clearance for the SPINE-TECH BONE HARVESTER. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Spine-Tech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 28, 1997 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spine-Tech, Inc. devices

Submission Details

510(k) Number K970040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1997
Decision Date February 28, 1997
Days to Decision 53 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 122d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.