MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM— 510(k) K110655

Substantially Equivalent

Mahe Medical GmbH

FDA 510(k) clearance K110655 for MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM, Substantially Equivalent on 2011-10-27. Applicant: Mahe Medical GmbH.

Clearance details

Applicant: Mahe Medical GmbH
Product code: Code NKB
Advisory panel: Orthopedic
Date received: 2011-03-07
Decision date: 2011-10-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tuttlingen, Bw, GR

Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.