510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031981Substantially Equivalent

2.4 Smartnail, Models 532416, 532425, 532435, 532445

Linvatec Biomaterials, Ltd., Largo FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031981 is the FDA 510(k) clearance record for 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445, a class II device, cleared for Linvatec Biomaterials, Ltd. on under FDA product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue). FDA records list 8 510(k) clearances for Linvatec Biomaterials, Ltd., from to . As of , FDA records show no recalls naming K031981.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MAI Fastener, Fixation, Biodegradable, Soft Tissue
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Linvatec Biomaterials, Ltd. 1311 Concept Blvd., Largo FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAI

Trailing 12 months
5 clearances under product code MAI in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MAI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260