Cleared Traditional

Southern Implants Instrument Trays

K210923 · Southern Implants (Pty), Ltd. · General Hospital

Mar 2022

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K210923 is an FDA 510(k) clearance for the Southern Implants Instrument Trays, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Southern Implants (Pty), Ltd. (Guateng, ZA). The FDA issued a Cleared decision on March 2, 2022, 338 days after receiving the submission on March 29, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K210923 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2021
Decision Date	March 02, 2022
Days to Decision	338 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850