Cleared Traditional

K791056 - 3M CEMENT REMOVER

K791056 is an FDA 510(k) clearance for 3M CEMENT REMOVER, manufactured by 3M Company. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K791056 · 3M Company · Orthopedic device
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Jul 1979
Decision
52d
Days
Class 1
Risk

K791056 is an FDA 510(k) clearance for the 3M CEMENT REMOVER. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 52 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 3M Company devices

FDA 510(k) Submission Details - K791056

510(k) Number K791056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1979
Decision Date July 30, 1979
Days to Decision 52 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
70d faster than avg
Panel avg: 122d · This submission: 52d
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 K791056.
OSTEO OSCILAIR
K803284 · Richard'S Medical Equip., Inc. · Jan 1981
ANSPACH INSTRUMENT CADDY
K801329 · The Anspach Effort, Inc. · Jun 1980
CEBOTOME DRILL
K800275 · American Sterilizer Co. · Feb 1980
SURGAIRTOME TWO
K781979 · American Sterilizer Co. · Dec 1978
WIREDRIVER
K772324 · American Sterilizer Co. · Jan 1978