510(k) K011380
K011380 is an FDA 510(k) premarket notification submitted by Bioplate, Inc. for the device "MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 2001. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Bioplate, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2001
- Date Received
- May 7, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Bone
- Device Class
- Class II
- Regulation Number
- 872.4760
- Review Panel
- DE
- Submission Type