REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement— 510(k) K172906

Clearance details

Applicant

Osteoremedies, LLC

Product code

Code KWL

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

2017-09-22

Decision date

2018-08-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Germantown, TN, US

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• K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component2024-10-02
• K231556 — SPECTRUM® GV Bone Cement2023-12-20
• K223650 — REMEDY Stemmed Knee Spacer2023-01-05
• K192995 — OsteoRemedies Hip Spacer System2020-01-10

Injury

523

Total

523

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 →