SPINAL SURGERY FRAME— 510(k) K882078

Substantially Equivalent

Karlin Technology, Inc.

FDA 510(k) clearance K882078 for SPINAL SURGERY FRAME, Substantially Equivalent on 1988-06-16. Applicant: Karlin Technology, Inc..

Clearance details

Applicant: Karlin Technology, Inc.
Product code: Code FWZ
Advisory panel: General, Plastic Surgery
Date received: 1988-05-17
Decision date: 1988-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marina Del Rey, CA, US

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.