CASPAR TITANIUM ALLOY BONE SCREWS— 510(k) K936269

Name: FDA 510(k) clearance K936269
Creator: U.S. Food and Drug Administration
Published: 1994-08-15

Substantially Equivalent for Some Indications

Aesculap, Inc.

FDA 510(k) clearance K936269 for CASPAR TITANIUM ALLOY BONE SCREWS, Substantially Equivalent for Some Indications on 1994-08-15. 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: 1993-12-30
Decision date: 1994-08-15
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.