The following data is part of a premarket notification filed by Pipeline Orthopedics with the FDA for Neo Knee System.
| Device ID | K131368 |
| 510k Number | K131368 |
| Device Name: | NEO KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria, VA 22314 |
| Contact | Terry Powell |
| Correspondent | Terry Powell PIPELINE ORTHOPEDICS 901 KING STREET, SUITE 200 Alexandria, VA 22314 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-10-03 |
| Summary: | summary |