FDA 510(k) clearance · back to tracker

RINGLOC + HYBRID ACETABULAR SYSTEM

Biomet, Inc. cleared K093235 on 2010-04-30, decision: substantially equivalent

K-number

K093235

Sponsor

Biomet, Inc.

Device

RINGLOC + HYBRID ACETABULAR SYSTEM

Class

Class III

Decision

Substantially Equivalent

Decision date

2010-04-30

Product code

KWA

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3330

Official FDA record

Open K093235on 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 K093235 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.