The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Elevate Spinal System.
| Device ID | K142559 |
| 510k Number | K142559 |
| Device Name: | ELEVATE Spinal System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Becky Ronner |
| Correspondent | Becky Ronner 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 | 2014-09-11 |
| Decision Date | 2015-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169484948 | K142559 | 000 |
| 00643169430761 | K142559 | 000 |
| 00643169430754 | K142559 | 000 |
| 00643169430747 | K142559 | 000 |
| 00643169430730 | K142559 | 000 |
| 00643169430723 | K142559 | 000 |
| 00643169430716 | K142559 | 000 |
| 00643169430709 | K142559 | 000 |
| 00643169430693 | K142559 | 000 |
| 00643169430686 | K142559 | 000 |
| 00643169430679 | K142559 | 000 |
| 00643169430662 | K142559 | 000 |
| 00643169430655 | K142559 | 000 |
| 00643169430648 | K142559 | 000 |
| 00643169430440 | K142559 | 000 |
| 00643169430433 | K142559 | 000 |
| 00763000880279 | K142559 | 000 |
| 00763000880262 | K142559 | 000 |
| 00643169430778 | K142559 | 000 |
| 00643169430785 | K142559 | 000 |
| 00643169430792 | K142559 | 000 |
| 00643169484931 | K142559 | 000 |
| 00643169432246 | K142559 | 000 |
| 00643169432239 | K142559 | 000 |
| 00643169432222 | K142559 | 000 |
| 00643169432215 | K142559 | 000 |
| 00643169432192 | K142559 | 000 |
| 00643169432185 | K142559 | 000 |
| 00643169432178 | K142559 | 000 |
| 00643169430884 | K142559 | 000 |
| 00643169430877 | K142559 | 000 |
| 00643169430860 | K142559 | 000 |
| 00643169430853 | K142559 | 000 |
| 00643169430846 | K142559 | 000 |
| 00643169430839 | K142559 | 000 |
| 00643169430822 | K142559 | 000 |
| 00643169430815 | K142559 | 000 |
| 00643169430808 | K142559 | 000 |
| 00763000880255 | K142559 | 000 |