The following data is part of a premarket notification filed by New Era Orthopedics, Llc with the FDA for Neo Total Knee System.
| Device ID | K142388 |
| 510k Number | K142388 |
| Device Name: | Neo Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | New Era Orthopedics, LLC 1214 Research Boulevard, Suite 1019 Hummelstown, PA 17036 |
| Contact | Craig Corrance |
| Correspondent | Terry Powell M SQUARED ASSOCIATES, INC. 575 Eighth Avenue, Suite 1212 New York, NY 10018 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-27 |
| Decision Date | 2014-12-05 |
| Summary: | summary |