FDA 510(k) clearance · back to tracker

Ntegrate Threaded Nail System

Nvision Biomedical Technologies cleared K261961 on 2026-10-14, decision: substantially equivalent

K-number

K261961

Sponsor

Nvision Biomedical Technologies

Device

Ntegrate Threaded Nail System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-14

Product code

HWC

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3040

Official FDA record

Open K261961on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.