The following data is part of a premarket notification filed by Porosteon, Inc. with the FDA for Porosteon Phusion Metal Cervical Cage.
| Device ID | K142041 |
| 510k Number | K142041 |
| Device Name: | POROSTEON PHUSION METAL CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | POROSTEON, INC. 100 PROMENADE SAINT LOUIS Notre-dame-de-l'lle-perrot,quebec, CA J7v 7p2 |
| Contact | Robert A Poggie, Phd |
| Correspondent | Robert A Poggie, Phd POROSTEON, INC. 100 PROMENADE SAINT LOUIS Notre-dame-de-l'lle-perrot,quebec, CA J7v 7p2 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-12-19 |
| Summary: | summary |