DANEK TISSUE CUTTING AND REMOVAL SYSTEM— 510(k) K922486

Name: FDA 510(k) clearance K922486
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K922486 for DANEK TISSUE CUTTING AND REMOVAL SYSTEM, Substantially Equivalent for Some Indications on 1993-10-12. Applicant: Sofamor Danek Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1992-05-27
Decision date: 1993-10-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

view all

K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26
K253523 — Freedom DS Decompression System2026-04-16
K252546 — VantageTM Lumbar Decompression Kit2026-03-12

More clearances from Sofamor Danek Mfg., Inc.

view all

K936294 — SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS1995-12-19
K930191 — DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY1995-09-26
K932029 — TSRH SPINAL SCREWS1995-01-20
K930710 — SENTRY POSTERIOR SPINAL SYSTEM1993-10-01
K930807 — SENTRY ANTERIOR SPINAL SYSTEM1993-10-01

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.