AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM— 510(k) K080992

Name: FDA 510(k) clearance K080992
Creator: U.S. Food and Drug Administration
Published: 2008-09-04

Substantially Equivalent

Aesculap Implant Systems, Inc.

FDA 510(k) clearance K080992 for AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM, Substantially Equivalent on 2008-09-04. Applicant: Aesculap Implant Systems, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap Implant Systems, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2008-04-07
Decision date: 2008-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

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
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Aesculap Implant Systems, Inc.

view all

K153629 — ArcadiusXP C Spinal System2016-05-25
K132421 — AESCULAP PEEK XP SPINAL IMPLANT SYSTEM2014-01-22
K123939 — S4 SPINAL SYSTEM2013-03-12
K123352 — S4 SPINAL SYSTEM2012-12-12
K111122 — AESCULAP SIBD XP SPINAL SYSTEM2011-08-04

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.