The following data is part of a premarket notification filed by Scandius Biomedical, Inc. with the FDA for Modification To Scandius Tritis Absorbable Tibial Reconstruction System.
| Device ID | K063497 |
| 510k Number | K063497 |
| Device Name: | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton, MA 01460 |
| Contact | Ralph Zimmerman |
| Correspondent | Ralph Zimmerman SCANDIUS BIOMEDICAL, INC. 11A BEAVER BROOK ROAD Littleton, MA 01460 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2006-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521513532 | K063497 | 000 |