The following data is part of a premarket notification filed by Interbody Innovations, Llp with the FDA for Zeus Small Cervical Cage And Large, Extra Large, Curved And Straight Lumbar Cages.
| Device ID | K081614 |
| 510k Number | K081614 |
| Device Name: | ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | INTERBODY INNOVATIONS, LLP 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | J.d. Webb |
| Correspondent | J.d. Webb INTERBODY INNOVATIONS, LLP 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2008-09-05 |
| Summary: | summary |