510(k) K132644
K132644 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU". The FDA issued a decision of Substantially Equivalent on Sep 19, 2013. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Corentec Co., Ltd. has 32 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 19, 2013
- Date Received
- Aug 26, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)