FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPTIVA SPINE FUSELOX CERVICAL CAGE
K Number: K110585
·
Decision Mar 25, 2011
Classifications
1
FEI Numbers
339
Registration Numbers
339
Same Product Code
348
Applicant Total
8
Review Days
24
Basic Information
- Device Name
- CAPTIVA SPINE FUSELOX CERVICAL CAGE
- K Number
- K110585
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Captiva Spine, Inc.
- Date Received
- March 1, 2011
- Decision Date
- March 25, 2011
- Product Code
- ODP
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Captiva Spine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | Jan 31, 2020 | Substantially Equivalent |
| K181229 | TirboLOX-C Cervical IBFD | Sep 19, 2018 | Substantially Equivalent |
| K180990 | TirboLOX-L Lumbar IBFD | Aug 13, 2018 | Substantially Equivalent |
| K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | Mar 19, 2018 | Substantially Equivalent |
| K120292 | CAPLOX II PEDICLE SCREW SYSTEM | Apr 13, 2012 | Substantially Equivalent |
| K111115 | CAPTIVA SPINE CAPLOX II SPINAL FIXATION SYSTEM | Sep 13, 2011 | Substantially Equivalent |
| K092017 | PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) | Dec 1, 2009 | Substantially Equivalent |