SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT— 510(k) K041449

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K041449 for SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT, Substantially Equivalent on 2004-07-01. Applicant: Interpore Cross Intl..

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2004-06-01
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.