The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa with the FDA for Perimeter Interbody Fusion Device.
| Device ID | K113642 |
| 510k Number | K113642 |
| Device Name: | PERIMETER INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Lauren Kamer |
| Correspondent | Lauren Kamer MEDTRONIC SOFAMOR DANEK USA 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 | 2011-12-12 |
| Decision Date | 2012-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994989956 | K113642 | 000 |