INTEGRATED ENDOSCOPY SYSTEM 1000— 510(k) K920800

Clearance details

Applicant

Biomet, Inc.

Product code

Code HRX

Device class

Class 2

Regulation

21 CFR 888.1100

Advisory panel

Orthopedic

Date received

1992-02-21

Decision date

1992-06-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Injury

623

Malfunction

11,257

Total

11,880

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 →

• Z-1818-2016 — Various trauma and sports medicine instruments and implants. Arthroscope.Class II·Terminated·Biomet, Inc.·20160401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K920800.