DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM— 510(k) K012081

Substantially Equivalent

Medtronic Sofamor Danek, Inc.

FDA 510(k) clearance K012081 for DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM, Substantially Equivalent on 2001-10-01. Applicant: Medtronic Sofamor Danek, Inc..

Clearance details

Applicant: Medtronic Sofamor Danek, Inc.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2001-07-03
Decision date: 2001-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.