510(k) K200108
K200108 is an FDA 510(k) premarket notification submitted by Gramercy Extremity Orthopedics, LLC for the device "GEO 1st MTP Joint Arthrodesis Plating System". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Gramercy Extremity Orthopedics, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2020
- Date Received
- January 17, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type