The following data is part of a premarket notification filed by Us Spine with the FDA for Phantom Plus Cage System.
| Device ID | K082801 |
| 510k Number | K082801 |
| Device Name: | PHANTOM PLUS CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | US SPINE 3600 FAU BLVD. SUITE 101 Boca Raton, FL 33431 |
| Contact | Peter Harris |
| Correspondent | Peter Harris US SPINE 3600 FAU BLVD. SUITE 101 Boca Raton, FL 33431 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-24 |
| Decision Date | 2008-12-22 |
| Summary: | summary |