Cleared Traditional

BONE PLATE

K893201 · Karlin Technology, Inc. · Orthopedic
Apr 1990
Decision
343d
Days
Class 2
Risk

About This 510(k) Submission

K893201 is an FDA 510(k) clearance for the BONE PLATE, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Karlin Technology, Inc. (Torrance, US). The FDA issued a Cleared decision on April 4, 1990, 343 days after receiving the submission on April 26, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K893201 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 1989
Decision Date April 04, 1990
Days to Decision 343 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

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