Cleared Traditional

CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM

K961320 · Buckman Co., Inc. · Orthopedic
Jun 1998
Decision
811d
Days
Class 2
Risk

About This 510(k) Submission

K961320 is an FDA 510(k) clearance for the CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on June 25, 1998, 811 days after receiving the submission on April 5, 1996. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K961320 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1996
Decision Date June 25, 1998
Days to Decision 811 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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