SCAPHIX, STAPLE, FIXATION, BONE— 510(k) K003033

Substantially Equivalent

Avanta Orthopaedics, Inc.

FDA 510(k) clearance K003033 for SCAPHIX, STAPLE, FIXATION, BONE, Substantially Equivalent on 2001-05-30. Applicant: Avanta Orthopaedics, Inc..

Clearance details

Applicant: Avanta Orthopaedics, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2000-09-28
Decision date: 2001-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.