The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Clydesdales Spinal System.
| Device ID | K112405 |
| 510k Number | K112405 |
| Device Name: | CLYDESDALES SPINAL SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994866523 | K112405 | 000 |