VU APOD INTERVERTABRAL BODY FUSION DEVICE
FDA 510(k) clearance K080822 · decided 2008-07-02
Clearance details
- K-number
- K080822
- Device name
- VU APOD INTERVERTABRAL BODY FUSION DEVICE
- Applicant
- Theken Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-03-24
- Decision date
- 2008-07-02
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all impla recall (Z-1475-2011) | Integra LifeSciences Corp. | 2011-03-02 |