APR POROUS HA HIP SYSTEM— 510(k) K973124

Substantially Equivalent for Some Indications

Sulzer Orthopedics, Inc.

FDA 510(k) clearance K973124 for APR POROUS HA HIP SYSTEM, Substantially Equivalent for Some Indications on 1997-11-03. Applicant: Sulzer Orthopedics, Inc..

Clearance details

Applicant: Sulzer Orthopedics, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1997-08-20
Decision date: 1997-11-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.