NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM— 510(k) K141253
Substantially EquivalentNew Era Orthopaedics, LLC
FDA 510(k) clearance K141253 for NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM, Substantially Equivalent on 2015-01-09. Applicant: New Era Orthopaedics, LLC.
Clearance details
- Applicant
- New Era Orthopaedics, LLC
- Product code
- Code MNI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Round Rock, TX, US
Adverse events under product code MNI
product code MNI- Injury
- 641
- Total
- 641
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.