MODIFIED OSTEOANALYZER (# SPSHA110/220)— 510(k) K891582

Name: FDA 510(k) clearance K891582
Creator: U.S. Food and Drug Administration
Published: 1989-09-12

Substantially Equivalent

Osteon, Inc.

FDA 510(k) clearance K891582 for MODIFIED OSTEOANALYZER (# SPSHA110/220), Substantially Equivalent on 1989-09-12. Applicant: Osteon, Inc.. Device class: 2.

Clearance details

Applicant: Osteon, Inc.
Product code: Code KGI
Device class: Class 2
Regulation: 21 CFR 892.1170
Advisory panel: Radiology
Date received: 1989-03-20
Decision date: 1989-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wahiawa, HI, US

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K843922 — OSTEON BONE MINERAL ANALYZER1985-04-02

Adverse events under product code KGI

product code KGI

Other: 1
Total: 1

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.