510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960642Substantially Equivalent

Nancy Nail

Landos, Inc., Malvern PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960642 is the FDA 510(k) clearance record for NANCY NAIL, a class II device, cleared for Landos, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 15 510(k) clearances for Landos, Inc., from to . As of , FDA records show no recalls naming K960642.

Clearance record

Decision date
Received
(93 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Landos, Inc. 100 Lindenwood Dr., Malvern PA
510(k) summary
Summary
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260