FDA 510(k) clearance · back to tracker

DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

Wrightmedicaltechnologyinc cleared K082924 on 2009-03-06, decision: substantially equivalent

K-number

K082924

Sponsor

Wrightmedicaltechnologyinc

Device

DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER

Class

Class III

Decision

Substantially Equivalent

Decision date

2009-03-06

Product code

KWA

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3330

Official FDA record

Open K082924on 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 K082924 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.

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Source

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