510(k) K961976
K961976 is an FDA 510(k) premarket notification submitted by Biomedics for the device "THE BIOPLATE FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 16, 1996. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Biomedics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1996
- Date Received
- May 20, 1996
- Clearance Type
- Traditional
- 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