Cleared Traditional

K831756 - ANSPACH 65

K831756 is an FDA 510(k) clearance for ANSPACH 65, manufactured by The Anspach Effort, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K831756 · The Anspach Effort, Inc. · Orthopedic device
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Sep 1983
Decision
120d
Days
Class 1
Risk

K831756 is an FDA 510(k) clearance for the ANSPACH 65,000. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by The Anspach Effort, Inc. (Walker, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 120 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 The Anspach Effort, Inc. devices

FDA 510(k) Submission Details - K831756

510(k) Number K831756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date September 29, 1983
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

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 K831756.
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · Micro-Aire Surgical Instruments, Inc. · May 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · Acufex Microsurgical, Inc. · Mar 1985
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · Cabot Medical Corp. · Apr 1984
MICRO OSCILLATING SAW
K811834 · Micro-Aire Surgical Instruments, Inc. · Jul 1981
CORB TM COUNTERROTATING BIOPSY NEEDLE
K811005 · Zimmer, Inc. · Jun 1981
OSTEO OSCILAIR
K803284 · Richard'S Medical Equip., Inc. · Jan 1981