The following data is part of a premarket notification filed by Global Orthopaedic Technology, Usa, Inc. with the FDA for Global Resurfacing Unicompartmental (gru) Knee.
| Device ID | K033351 |
| 510k Number | K033351 |
| Device Name: | GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 |
| Contact | Carl Knobloch |
| Correspondent | Carl Knobloch GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-20 |
| Decision Date | 2004-03-11 |
| Summary: | summary |