SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM

Fastener, Fixation, Biodegradable, Soft Tissue

SCANDIUS BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Scandius Biomedical, Inc. with the FDA for Scandius Tritis Absorbable Tibial Reconstruction System.

Pre-market Notification Details

• Device ID: K060522
• 510k Number: K060522
• Device Name: SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
• Classification: Fastener, Fixation, Biodegradable, Soft Tissue
• Applicant: SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton, MA 01460
• Contact: Eric Bannon
• Correspondent: Eric Bannon; SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton, MA 01460
• Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-02-27
• Decision Date: 2006-04-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521513877	K060522	000
10884521513495	K060522	000
10884521513471	K060522	000
10884521513457	K060522	000
10884521513358	K060522	000
10884521513341	K060522	000
10884521513334	K060522	000