ODONTIT AUTOGENOUS BONE COLLECTION DEVICE— 510(k) K971036

Name: FDA 510(k) clearance K971036
Creator: U.S. Food and Drug Administration
Published: 1997-06-03

Substantially Equivalent

Interpore Intl.

FDA 510(k) clearance K971036 for ODONTIT AUTOGENOUS BONE COLLECTION DEVICE, Substantially Equivalent on 1997-06-03. Applicant: Interpore Intl.. Device class: 1.

Clearance details

Applicant: Interpore Intl.
Product code: Code GCY
Device class: Class 1
Regulation: 21 CFR 878.4680
Advisory panel: General, Plastic Surgery
Date received: 1997-03-20
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE1997-10-30
K960945 — IMZ MEMBRANE TACK SYSTEM1996-05-24
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Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.