Cleared Traditional

HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM

K982531 · Howmedica Corp. · Orthopedic
Oct 1998
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K982531 is an FDA 510(k) clearance for the HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on October 16, 1998, 88 days after receiving the submission on July 20, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K982531 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1998
Decision Date October 16, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRS — Plate, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

Similar Devices — HRS Plate, Fixation, Bone

All 1291
Xpert Hand
K253906 · Newclip Technics · Mar 2026
DePuy Synthes VOLT? Proximal Tibia 3.5 Plating System
K260069 · Synthes GmbH · Mar 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · Arthrex, Inc. · Mar 2026
VOLT? Ankle Trauma 2.7/3.5 Plating System; VOLT? Calcaneus 2.7 Plating System
K254054 · Synthes GmbH · Mar 2026
HKT Anatomical Locking Trauma System
K254249 · Hankil Tech Medical Co., Ltd. · Feb 2026
RIB LINK? Fixation System
K252166 · Globus Medical, Inc. · Feb 2026