The following data is part of a premarket notification filed by Ouroboros Medical with the FDA for Xcage Interbody Fusion System.
| Device ID | K133514 |
| 510k Number | K133514 |
| Device Name: | XCAGE INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | OUROBOROS MEDICAL 47757 FREMONT BLVD Fremont, CA 94538 |
| Contact | John To |
| Correspondent | John To OUROBOROS MEDICAL 47757 FREMONT BLVD Fremont, CA 94538 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850231007862 | K133514 | 000 |
| 00850231007398 | K133514 | 000 |
| 00850231007404 | K133514 | 000 |
| 00850231007411 | K133514 | 000 |
| 00850231007428 | K133514 | 000 |
| 00850231007466 | K133514 | 000 |
| 00850231007473 | K133514 | 000 |
| 00850231007565 | K133514 | 000 |
| 00850231007572 | K133514 | 000 |
| 00850231007589 | K133514 | 000 |
| 00850231007596 | K133514 | 000 |
| 00850231007602 | K133514 | 000 |
| 00850231007626 | K133514 | 000 |
| 00850231007633 | K133514 | 000 |
| 00850231007091 | K133514 | 000 |