The following data is part of a premarket notification filed by Captiva Spine, Inc with the FDA for Captiva Spine Fuselox Cervical Cage.
| Device ID | K110585 |
| 510k Number | K110585 |
| Device Name: | CAPTIVA SPINE FUSELOX CERVICAL CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CAPTIVA SPINE, INC 2361 NW 105TH LANE Sunrise, FL 33322 |
| Contact | John Sanders |
| Correspondent | John Sanders CAPTIVA SPINE, INC 2361 NW 105TH LANE Sunrise, FL 33322 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739FCP12140 | K110585 | 000 |
| M739FCL12090 | K110585 | 000 |
| M739FCL12080 | K110585 | 000 |
| M739FCL12070 | K110585 | 000 |
| M739FCL12060 | K110585 | 000 |
| M739FCL12050 | K110585 | 000 |
| M7391410714120 | K110585 | 000 |
| M7391410714110 | K110585 | 000 |
| M7391410714100 | K110585 | 000 |
| M7391410714090 | K110585 | 000 |
| M7391410714080 | K110585 | 000 |
| M7391410714070 | K110585 | 000 |
| M7391410714060 | K110585 | 000 |
| M739FCL12100 | K110585 | 000 |
| M739FCL12110 | K110585 | 000 |
| M739FCP12130 | K110585 | 000 |
| M739FCP12120 | K110585 | 000 |
| M739FCP12110 | K110585 | 000 |
| M739FCP12100 | K110585 | 000 |
| M739FCP12090 | K110585 | 000 |
| M739FCP12080 | K110585 | 000 |
| M739FCP12070 | K110585 | 000 |
| M739FCP12060 | K110585 | 000 |
| M739FCP12050 | K110585 | 000 |
| M739FCL12140 | K110585 | 000 |
| M739FCL12130 | K110585 | 000 |
| M739FCL12120 | K110585 | 000 |
| M7391410714050 | K110585 | 000 |