HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System— 510(k) K222282
Substantially EquivalentHospital Equipment Manufacturing Company
FDA 510(k) clearance K222282 for HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, Substantially Equivalent on 2022-10-27. Applicant: Hospital Equipment Manufacturing Company.
Clearance details
- Applicant
- Hospital Equipment Manufacturing Company
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Noida, IN
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.