Cleared Traditional

K960642 - NANCY NAIL

K960642 is an FDA 510(k) clearance for NANCY NAIL, manufactured by Landos, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K960642 · Landos, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
93d
Days
Class 2
Risk

K960642 is an FDA 510(k) clearance for the NANCY NAIL. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Landos, Inc. (Malvern, US). The FDA issued a Cleared decision on May 17, 1996 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Landos, Inc. devices

FDA 510(k) Submission Details - K960642

510(k) Number K960642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1996
Decision Date May 17, 1996
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 131
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K960642.
BLOCK STOP WIRES
K964087 · Ferguson Medical · Nov 1996
RMS K-WIRE
K963367 · Rms Div. · Oct 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · Synvasive Technology, Inc. · Sep 1996
K-WIRE
K960482 · American Medical Specialties, Inc. · Apr 1996
STEINMAN PIN
K960483 · American Medical Specialties, Inc. · Apr 1996
STERILE KIRSCHNER WIRES AND STEINMANN PINS
K960385 · Depuy, Inc. · Mar 1996