FDA 510(k) clearance · back to tracker

DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

Encore Medical L.P. cleared K092331 on 2010-03-03, decision: substantially equivalent

K-number

K092331

Sponsor

Encore Medical L.P.

Device

DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;

Class

Class III

Decision

Substantially Equivalent

Decision date

2010-03-03

Product code

KWA

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3330

Official FDA record

Open K092331on 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 K092331 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.