510(k) K133906
K133906 is an FDA 510(k) premarket notification submitted by Medicrea International for the device "C-JAWS CERVICAL COMPRESSIVE STAPLE". The FDA issued a decision of Substantially Equivalent on July 24, 2014. The device falls under product code PHQ (Anterior Staple As Supplemental Fixation For Fusion), a Class II device regulated under 21 CFR 888.3060. Medicrea International has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2014
- Date Received
- December 23, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anterior Staple As Supplemental Fixation For Fusion
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
Anterior cervical device for supplemental fixation to support a fusion.