TOTAL

Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene

TREACE MEDICAL, INC.

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

Pre-market Notification Details

• Device ID: K822367
• 510k Number: K822367
• Device Name: TOTAL
• Classification: Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene
• Applicant: TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: LBN
• CFR Regulation Number: 874.3495 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-08-06
• Decision Date: 1982-09-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00681490035460	K822367	000
00681490035453	K822367	000
00681490035446	K822367	000
00681490035439	K822367	000
00681490035422	K822367	000
00681490035415	K822367	000
00681490035408	K822367	000
00763000035389	K822367	000
00763000035372	K822367	000