The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Tibial Spacer For The Natural-knee Ii Cemented Modular Tibial Baseplate.
| Device ID | K031183 |
| 510k Number | K031183 |
| Device Name: | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Robert M Wolfarth |
| Correspondent | Robert M Wolfarth CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-15 |
| Decision Date | 2003-07-14 |
| Summary: | summary |