510(k) K072436
K072436 is an FDA 510(k) premarket notification submitted by Bk Meditech, Co., Ltd. for the device "MEGA SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 1, 2007. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Bk Meditech, Co., Ltd. has 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 1, 2007
- Date Received
- Aug 30, 2007
- Clearance Type
- Traditional
- 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)