The following data is part of a premarket notification filed by Eden Spine, Llc with the FDA for Giza(r) Vertebral Body Replacement.
| Device ID | K112429 |
| 510k Number | K112429 |
| Device Name: | GIZA(R) VERTEBRAL BODY REPLACEMENT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | EDEN SPINE, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen EDEN SPINE, LLC 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2012-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167930319 | K112429 | 000 |
| 07640167930029 | K112429 | 000 |
| 07640167930036 | K112429 | 000 |
| 07640167930043 | K112429 | 000 |
| 07640167930050 | K112429 | 000 |
| 07640167930067 | K112429 | 000 |
| 07640167930265 | K112429 | 000 |
| 07640167930272 | K112429 | 000 |
| 07640167930289 | K112429 | 000 |
| 07640167930296 | K112429 | 000 |
| 07640167930302 | K112429 | 000 |
| 07640167930012 | K112429 | 000 |