510(k) K143338
K143338 is an FDA 510(k) premarket notification submitted by Osteomed LP for the device "Argulated Locking Plates". The FDA issued a decision of Substantially Equivalent on April 1, 2015. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760. Osteomed LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2015
- Date Received
- November 20, 2014
- 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