ELEVATOR

Elevator, Ent

TREACE MEDICAL, INC.

The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Elevator.

Pre-market Notification Details

• Device ID: K841356
• 510k Number: K841356
• Device Name: ELEVATOR
• Classification: Elevator, Ent
• Applicant: TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KAD
• CFR Regulation Number: 874.4420 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-02
• Decision Date: 1984-07-18