510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K210285Substantially Equivalent

Adaptable Ortho Innovations Intramedullary Nail System

Adaptable Ortho Innovations, LLC, Potsdam NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210285 is the FDA 510(k) clearance record for Adaptable Ortho Innovations Intramedullary Nail System, a class II device, cleared for Adaptable Ortho Innovations, LLC on under FDA product code HSB (Rod, Fixation, Intramedullary And Accessories). FDA records list one 510(k) clearance for Adaptable Ortho Innovations, LLC. As of , FDA records show no recalls naming K210285.

Clearance record

Decision date
Received
(44 days to decision)
Product code
HSB Rod, Fixation, Intramedullary And Accessories
Regulation
21 CFR 888.3020
Device class
Class II
Review panel
Orthopedic
Applicant
Adaptable Ortho Innovations, LLC 65 Main St., Potsdam NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSB

Trailing 12 months
19 clearances under product code HSB in the twelve months to October 2026, March 2026 the highest month at 7.
Show the numbers
Monthly 510(k) clearances under FDA product code HSB, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20267
April 20261
May 20262
June 20265
July 20260
August 20260
September 20261
October 20260