Cleared Traditional

Guided Surgery Kit

K231087 · Implant Direct Sybron Manufacturing, LLC · General Hospital
Aug 2023
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K231087 is an FDA 510(k) clearance for the Guided Surgery Kit, a Drill, Bone, Powered (Class II — Special Controls, product code DZI), submitted by Implant Direct Sybron Manufacturing, LLC (Thousand Oaks, US). The FDA issued a Cleared decision on August 16, 2023, 121 days after receiving the submission on April 17, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K231087 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2023
Decision Date August 16, 2023
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code DZI — Drill, Bone, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120

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