The following data is part of a premarket notification filed by Innvotec Surgical, Inc. with the FDA for Sec Ibf Cage.
| Device ID | K093669 |
| 510k Number | K093669 |
| Device Name: | SEC IBF CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | INNVOTEC SURGICAL, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton INNVOTEC SURGICAL, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2010-03-18 |
| Summary: | summary |