ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW— 510(k) K923256

Name: FDA 510(k) clearance K923256
Creator: U.S. Food and Drug Administration
Published: 1992-10-09

Substantially Equivalent

Alphatec Mfg., Inc.

FDA 510(k) clearance K923256 for ALPHATEC 2.7 MM CANNULATED CORTICAL LAG SCREW, Substantially Equivalent on 1992-10-09. Applicant: Alphatec Mfg., Inc.. Device class: 2.

Clearance details

Applicant: Alphatec Mfg., Inc.
Product code: Code HWC
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1992-07-02
Decision date: 1992-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Desert, CA, US

Download summary PDF View on FDA.gov ↗

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K993513 — DELTALOC ANTERIOR CERVICAL PLATE SYSTEM2000-04-26
K993873 — ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD2000-01-03

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.