Cleared Traditional

K970345 - ALIGNMENT INSTRUMENT

K970345 is the FDA 510(k) clearance for ALIGNMENT INSTRUMENT by Richard Wolf Medical Instruments Corp.. It is a Class 1 Orthopedic device (product code HSZ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970345 · Richard Wolf Medical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
Class 1
Risk

K970345 is an FDA 510(k) clearance for the ALIGNMENT INSTRUMENT. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on April 29, 1997 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Richard Wolf Medical Instruments Corp. devices

Submission Details

510(k) Number K970345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1997
Decision Date April 29, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & 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.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K970345.
ASPACH 65,000 (MODIFICATION)
K955084 · The Anspach Effort, Inc. · Jan 1996
ETHICON DRILL BIT AND DRILL GUIDE
K944590 · Ethicon, Inc. · May 1995
PNEUMATIC WIRE TENSIONER
K942760 · Smith & Nephew Richards, Inc. · Sep 1994
ARTHREX CIRCULAR HARVESTING SAW
K941681 · Arthrex, Inc. · Aug 1994
PNEUMATIC WIRE TENSIONER
K934431 · Smith & Nephew Richards, Inc. · Jan 1994
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · Micro-Aire Surgical Instruments, Inc. · Nov 1990