MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER— 510(k) K934366

Name: FDA 510(k) clearance K934366
Creator: U.S. Food and Drug Administration
Published: 1994-10-07

Substantially Equivalent for Some Indications

Mitek Surgical Products, Inc.

FDA 510(k) clearance K934366 for MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER, Substantially Equivalent for Some Indications on 1994-10-07. Applicant: Mitek Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-09-07
Decision date: 1994-10-07
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.