ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM— 510(k) K020356

Name: FDA 510(k) clearance K020356
Creator: U.S. Food and Drug Administration
Published: 2002-07-23

Substantially Equivalent

Alphatec Mfg., Inc.

FDA 510(k) clearance K020356 for ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM, Substantially Equivalent on 2002-07-23. Applicant: Alphatec Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2002-02-04
Decision date: 2002-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Alphatec Mfg., Inc.

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K033090 — ICON POLYAXIAL PEDICLE SCREW SYSTEM2004-03-26
K023299 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2002-12-11
K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM2000-04-26
K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD2000-01-03
K992350 — PYLON INTRAMEDULLAARY NAIL SYSTEM1999-09-22

Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.