The following data is part of a premarket notification filed by Scandius Biomedical, Inc. with the FDA for Scandius Acl Reconstruction System.
| Device ID | K041749 |
| 510k Number | K041749 |
| Device Name: | SCANDIUS ACL RECONSTRUCTION SYSTEM |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-29 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521548343 | K041749 | 000 |
| 10884521513617 | K041749 | 000 |
| 10884521513624 | K041749 | 000 |
| 10884521513648 | K041749 | 000 |
| 10884521513679 | K041749 | 000 |
| 10884521513686 | K041749 | 000 |
| 10884521513693 | K041749 | 000 |
| 10884521513778 | K041749 | 000 |
| 10884521513785 | K041749 | 000 |
| 10884521513792 | K041749 | 000 |
| 10884521513808 | K041749 | 000 |
| 10884521513815 | K041749 | 000 |
| 10884521513822 | K041749 | 000 |
| 10884521513839 | K041749 | 000 |
| 10884521513853 | K041749 | 000 |
| 10884521513570 | K041749 | 000 |