MITEK KNOTLESS ANCHOR— 510(k) K974345

Name: FDA 510(k) clearance K974345
Creator: U.S. Food and Drug Administration
Published: 1998-02-13

Substantially Equivalent

Mitek Products

FDA 510(k) clearance K974345 for MITEK KNOTLESS ANCHOR, Substantially Equivalent on 1998-02-13. Applicant: Mitek Products. Device class: 2.

Clearance details

Applicant: Mitek Products
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1997-11-19
Decision date: 1998-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

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K262677 — Iconix Knotless T2026-08-27
K262047 — Grappler Suture Anchor System2026-08-03
K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

More clearances from Mitek Products

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K013572 — MITEK BIOCRYL INTERFERENCE SCREWS2002-03-14
K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT2002-02-06
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 MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.