ALPHATEC WIRE EXTERNAL FIXATION SYSTEM— 510(k) K980788

Name: FDA 510(k) clearance K980788
Creator: U.S. Food and Drug Administration
Published: 1998-05-22

Substantially Equivalent

Alphatec Mfg., Inc.

FDA 510(k) clearance K980788 for ALPHATEC WIRE EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 1998-05-22. Applicant: Alphatec Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1998-03-02
Decision date: 1998-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

Download summary PDF View on FDA.gov ↗

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K033090 — ICON POLYAXIAL PEDICLE SCREW SYSTEM2004-03-26
K023299 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2002-12-11
K020356 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM2002-07-23
K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM2000-04-26
K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD2000-01-03

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.