MAHE FIXATION PLATE AND SCREW SYSTEM— 510(k) K102845

Name: FDA 510(k) clearance K102845
Creator: U.S. Food and Drug Administration
Published: 2011-05-13

Substantially Equivalent

Mahe Medical GmbH

FDA 510(k) clearance K102845 for MAHE FIXATION PLATE AND SCREW SYSTEM, Substantially Equivalent on 2011-05-13. Applicant: Mahe Medical GmbH. Device class: 2.

Clearance details

Applicant: Mahe Medical GmbH
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2010-09-29
Decision date: 2011-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, Bw, GR

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15
K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19

More clearances from Mahe Medical GmbH

view all

K110655 — MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM2011-10-27

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.