2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424— 510(k) K083364

Name: FDA 510(k) clearance K083364
Creator: U.S. Food and Drug Administration
Published: 2008-12-11

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K083364 for 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424, Substantially Equivalent on 2008-12-11. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2008-11-13
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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.