FDA 510(k) clearance · back to tracker

PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER

Wrightmedicaltechnologyinc cleared K113019 on 2011-11-10, decision: substantially equivalent

K-number

K113019

Sponsor

Wrightmedicaltechnologyinc

Device

PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER

Class

Class III

Decision

Substantially Equivalent

Decision date

2011-11-10

Product code

KWA

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3330

Official FDA record

Open K113019on 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.

Use this as a predicate

Drop K113019 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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