GEO 1st MTP Joint Arthrodesis Plating System— 510(k) K200108
Substantially EquivalentGramercy Extremity Orthopedics, LLC
FDA 510(k) clearance K200108 for GEO 1st MTP Joint Arthrodesis Plating System, Substantially Equivalent on 2020-03-26. Applicant: Gramercy Extremity Orthopedics, LLC. Device class: 2.
Clearance details
- Applicant
- Gramercy Extremity Orthopedics, LLC
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richardson, TX, US
Recent devices under product code HRS
view allMore clearances from Gramercy Extremity Orthopedics, LLC
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200108
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200108.
Data sourced from openFDA. This site is unofficial and independent of the FDA.