RESOLVE QUICKANCHOR— 510(k) K993575

Name: FDA 510(k) clearance K993575
Creator: U.S. Food and Drug Administration
Published: 1999-12-29

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K993575 for RESOLVE QUICKANCHOR, Substantially Equivalent on 1999-12-29. Applicant: Mitek Products. Device class: 2.

Clearance details

Applicant: Mitek Products
Product code: Code DZL
Device class: Class 2
Regulation: 21 CFR 872.4880
Advisory panel: Dental
Date received: 1999-10-21
Decision date: 1999-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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K002639 — BIOKNOTLESS ANCHOR2001-05-11
K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM2001-05-09
K002406 — MITEK 2GII MENISCAL REPAIR SYSTEM2001-02-15

Adverse events under product code DZL

product code DZL

Injury: 168
Total: 168

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.