AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45— 510(k) K081011

Substantially Equivalent

Arex USA

FDA 510(k) clearance K081011 for AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45, Substantially Equivalent on 2008-11-07. Applicant: Arex USA.

Clearance details

Applicant: Arex USA
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-04-09
Decision date: 2008-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collegeville, PA, US

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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.