METATARSAL DECOMPRESSION IMPLANT, MODEL 100— 510(k) K090127

Substantially Equivalent

Solana Surgical, LLC

FDA 510(k) clearance K090127 for METATARSAL DECOMPRESSION IMPLANT, MODEL 100, Substantially Equivalent on 2009-05-01. Applicant: Solana Surgical, LLC.

Clearance details

Applicant: Solana Surgical, LLC
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2009-01-21
Decision date: 2009-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oceanside, CA, US

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Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.