PREMIER-TOTAL HIP— 510(k) K894051

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K894051 for PREMIER-TOTAL HIP, Substantially Equivalent on 1989-08-28. Applicant: Intermedics Orthopedics.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code LWJ
Advisory panel: Orthopedic
Date received: 1989-06-07
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.