The following data is part of a premarket notification filed by Global Orthopaedic Technology, Usa, Inc. with the FDA for Rbk Patella Femoral Knee.
| Device ID | K050473 |
| 510k Number | K050473 |
| Device Name: | RBK PATELLA FEMORAL KNEE |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 -5018 |
| Contact | Carl Knobloch |
| Correspondent | Carl Knobloch GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. 5349 RED LEAF COURT Oviedo, FL 32765 -5018 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-24 |
| Decision Date | 2005-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09340499022710 | K050473 | 000 |
| 09340499004631 | K050473 | 000 |
| 09340499004648 | K050473 | 000 |
| 09340499004655 | K050473 | 000 |
| 09340499004662 | K050473 | 000 |
| 09340499017730 | K050473 | 000 |
| 09340499017747 | K050473 | 000 |
| 09340499017754 | K050473 | 000 |
| 09340499017761 | K050473 | 000 |
| 09340499017778 | K050473 | 000 |
| 09340499017785 | K050473 | 000 |
| 09340499017792 | K050473 | 000 |
| 09340499017808 | K050473 | 000 |
| 09340499022703 | K050473 | 000 |
| 09340499004624 | K050473 | 000 |