The following data is part of a premarket notification filed by Orthocor Medical with the FDA for Orthocor Knee System, Median, Large, X-large.
| Device ID | K092044 |
| 510k Number | K092044 |
| Device Name: | ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | ORTHOCOR MEDICAL 9907 OAKLEAF WAY Mccordsville, IN 46055 |
| Contact | Ines Burgos |
| Correspondent | Ines Burgos ORTHOCOR MEDICAL 9907 OAKLEAF WAY Mccordsville, IN 46055 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-12-18 |
| Summary: | summary |