MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k) clearance K080690 · decided 2008-04-25
Clearance details
- K-number
- K080690
- Device name
- MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM
- Applicant
- Theken Spine, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-03-11
- Decision date
- 2008-04-25
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- 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 |
|---|---|---|
| Manta Ray" Anterior Cervical Plate (ACP) System, Intended use: The Manta Ray ACP System is recall (Z-2197-2011) | Integra LifeSciences Corp. | 2011-05-13 |
| Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the pl recall (Z-0087-2011) | Theken Spine Llc | 2010-10-19 |