The following data is part of a premarket notification filed by Scandius Biomedical, Inc. with the FDA for Scandius Tritis Tibial Acl Reconstruction System.
| Device ID | K052810 |
| 510k Number | K052810 |
| Device Name: | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-04 |
| Decision Date | 2005-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521514133 | K052810 | 000 |
| 10884521513891 | K052810 | 000 |
| 10884521513884 | K052810 | 000 |
| 10884521514102 | K052810 | 000 |
| 10884521514096 | K052810 | 000 |
| 10884521514089 | K052810 | 000 |
| 10884521514072 | K052810 | 000 |
| 10884521514065 | K052810 | 000 |
| 10884521514058 | K052810 | 000 |
| 10884521513914 | K052810 | 000 |
| 10884521513921 | K052810 | 000 |
| 10884521513983 | K052810 | 000 |
| 10884521513952 | K052810 | 000 |
| 10884521513907 | K052810 | 000 |
| 10884521514027 | K052810 | 000 |
| 10884521514010 | K052810 | 000 |
| 10884521514003 | K052810 | 000 |
| 10884521513945 | K052810 | 000 |
| 10884521513938 | K052810 | 000 |
| 10884521514034 | K052810 | 000 |