The following data is part of a premarket notification filed by Captiva Spine with the FDA for Captiva Spine Fuselox Cervical Ibf System.
| Device ID | K142586 |
| 510k Number | K142586 |
| Device Name: | Captiva Spine FuselOX Cervical IBF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CAPTIVA SPINE 967 ALTERNATE A1A #1 Jupiter, FL 33477 |
| Contact | Tamala J Wampler |
| Correspondent | Rich Jansen, Pharm.d. Silver Pine Consulting 11821 Bramble Cove Dr, Ft.myers, FL 33905 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2015-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M739FCP1212 | K142586 | 000 |
| M739FCL1206 | K142586 | 000 |
| M739FCL1207 | K142586 | 000 |
| M739FCL1208 | K142586 | 000 |
| M739FCL1209 | K142586 | 000 |
| M739FCL1210 | K142586 | 000 |
| M739FCL1211 | K142586 | 000 |
| M739FCL1212 | K142586 | 000 |
| M739FCP1205 | K142586 | 000 |
| M739FCP1206 | K142586 | 000 |
| M739FCP1207 | K142586 | 000 |
| M739FCP1208 | K142586 | 000 |
| M739FCP1209 | K142586 | 000 |
| M739FCP1210 | K142586 | 000 |
| M739FCP1211 | K142586 | 000 |
| M739FCL1205 | K142586 | 000 |