ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION— 510(k) K922766

Name: FDA 510(k) clearance K922766
Creator: U.S. Food and Drug Administration
Published: 1993-07-09

Unknown

Acufex Microsurgical, Inc.

FDA 510(k) clearance K922766 for ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION, Unknown on 1993-07-09. Applicant: Acufex Microsurgical, Inc.. Device class: 2.

Clearance details

Applicant: Acufex Microsurgical, Inc.
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1992-06-02
Decision date: 1993-07-09
Decision: Unknown
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTY

view all

K262722 — Primal K-Wire (P99-193-1410)2026-08-28
K253325 — ZipToe Hammertoe Fusion System2025-12-29
K252657 — Impact PEEK Union Nail System2025-09-19
K250315 — RONAVIS FX (FX-001)2025-08-01
K251362 — PediFlex Flexible Nail System2025-06-24

More clearances from Acufex Microsurgical, Inc.

view all

K961555 — ACUFEX TAG BIOABSORBABLE ANCHORS1996-07-10
K961853 — PROLINE FAST PASS ARTHOSCOPIC NEEDLE PASSER1996-06-21
K954246 — ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW1996-02-15
K952535 — ACUFEX ENDOBUTTON TAPE1996-02-08
K953276 — ACUFEX TAG DELIVERY SYSTEM1995-10-05

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.