AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION— 510(k) K953720

Name: FDA 510(k) clearance K953720
Creator: U.S. Food and Drug Administration
Published: 1995-11-02

Substantially Equivalent for Some Indications

Aesculap, Inc.

FDA 510(k) clearance K953720 for AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION, Substantially Equivalent for Some Indications on 1995-11-02. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 1995-08-09
Decision date: 1995-11-02
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.