Cleared Traditional

OSTEOMED M3 SYSTEM (SBF SYSTEM)

K924138 · Osteomed Corp. · Dental
Feb 1993
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K924138 is an FDA 510(k) clearance for the OSTEOMED M3 SYSTEM (SBF SYSTEM), a Plate, Bone (Class II — Special Controls, product code JEY), submitted by Osteomed Corp. (Glendale, US). The FDA issued a Cleared decision on February 17, 1993, 183 days after receiving the submission on August 18, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K924138 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1992
Decision Date February 17, 1993
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code JEY — Plate, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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