BONUTTI ANCHOR— 510(k) K934183

Name: FDA 510(k) clearance K934183
Creator: U.S. Food and Drug Administration
Published: 1996-04-03

Substantially Equivalent for Some Indications

Apogee Medical Products, Inc.

FDA 510(k) clearance K934183 for BONUTTI ANCHOR, Substantially Equivalent for Some Indications on 1996-04-03. Applicant: Apogee Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Apogee Medical Products, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1993-08-26
Decision date: 1996-04-03
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Effingham, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

view all

K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
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

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.