MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING— 510(k) K971206

Name: FDA 510(k) clearance K971206
Creator: U.S. Food and Drug Administration
Published: 1998-02-11

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K971206 for MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING, Substantially Equivalent for Some Indications on 1998-02-11. Applicant: Howmedica Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Corp.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 1997-03-12
Decision date: 1998-02-11
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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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.