The following data is part of a premarket notification filed by Kapp Surgical Instrument, Inc. with the FDA for Mondeal Radius Ho System, Model Ks-mr-2005.
| Device ID | K050655 |
| 510k Number | K050655 |
| Device Name: | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 |
| Classification | Plate, Fixation, Bone |
| Applicant | KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Contact | Albert Santilli |
| Correspondent | Albert Santilli KAPP SURGICAL INSTRUMENT, INC. 4919 WARRENSVILLE CENTER RD. Cleveland, OH 44128 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-08-08 |
| Summary: | summary |