New Era Orthopaedics, LLc
FDA Regulatory Profile
New Era Orthopaedics, LLc appears in FDA public data with 1 recall, 1 510(k) clearance, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-2604-2018, Class II) was initiated on February 13, 2017. Its most recent 510(k) clearance was granted on January 9, 2015.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2604-2018 | Class II | Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07 | February 13, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K141253 | NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM | January 9, 2015 |