The following data is part of a premarket notification filed by Advanced Bio-surfaces, Inc. with the FDA for Orthoglide Medical Knee Implant And Instruments, Models 9063, 9064, 9065, 9060, 9062, 9057, 9056.
| Device ID | K053094 |
| 510k Number | K053094 |
| Device Name: | ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 |
| Classification | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) |
| Applicant | ADVANCED BIO-SURFACES, INC. 5909 BAKER ROAD, SUITE 550 Minnetonka, MN 55345 |
| Contact | Phillip B Jarvi |
| Correspondent | Phillip B Jarvi ADVANCED BIO-SURFACES, INC. 5909 BAKER ROAD, SUITE 550 Minnetonka, MN 55345 |
| Product Code | HSH |
| CFR Regulation Number | 888.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-03 |
| Decision Date | 2006-02-06 |
| Summary: | summary |