The following data is part of a premarket notification filed by Advanced Bio-surfaces, Inc. with the FDA for Orthoglide Lateral Knee Implant And Instruments.
| Device ID | K073233 |
| 510k Number | K073233 |
| Device Name: | ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS |
| Classification | Prosthesis, Knee, Hemi-, Tibial, Resurfacing (uncemented) |
| Applicant | ADVANCED BIO-SURFACES, INC. 14289 YELLOW PINE STREET Andover, MN 55345 |
| Contact | Philip B Jarvi |
| Correspondent | Philip B Jarvi ADVANCED BIO-SURFACES, INC. 14289 YELLOW PINE STREET Andover, 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 | 2007-11-15 |
| Decision Date | 2008-01-28 |
| Summary: | summary |