Cleared Traditional

K861822 - MALIS SURGICAL MESH FOR SKULL /SPINAL C...

K861822 is an FDA 510(k) clearance for MALIS SURGICAL MESH FOR SKULL /SPINAL C..., manufactured by Valley Forge Scientific Corp.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K861822 · Valley Forge Scientific Corp. · Neurology device
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Jul 1986
Decision
60d
Days
Class 2
Risk

K861822 is an FDA 510(k) clearance for the MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - the FDA neurology device 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 Valley Forge Scientific Corp. devices

FDA 510(k) Submission Details - K861822

510(k) Number K861822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1986
Decision Date July 11, 1986
Days to Decision 60 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 148d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GWO Plate, Cranioplasty, Preformed, Alterable

All 34
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