MITEK ANCHOR— 510(k) K892126

Name: FDA 510(k) clearance K892126
Creator: U.S. Food and Drug Administration
Published: 1989-09-19

Substantially Equivalent

Mitek Surgical Products, Inc.

FDA 510(k) clearance K892126 for MITEK ANCHOR, Substantially Equivalent on 1989-09-19. Applicant: Mitek Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1989-03-30
Decision date: 1989-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dedham, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Mitek Surgical Products, Inc.

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K953560 — MITEK THREADED ANCHOR (FASTIN)1996-01-31
K953877 — MITEK GII ANCHOR1995-12-29
K936311 — MITEK MINI ANCHOR1995-10-31
K941599 — MITEK ABSORBABLE ANCHOR1995-10-24
K944051 — ABSORBALBE ANCHOR1995-08-02

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.