The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Sky Bone Expander System (sky System).
| Device ID | K040612 |
| 510k Number | K040612 |
| Device Name: | SKY BONE EXPANDER SYSTEM (SKY SYSTEM) |
| Classification | Arthroscope |
| Applicant | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT ST. Herzliya, IL 46728 |
| Contact | Yael Rubin |
| Correspondent | Yael Rubin DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT ST. Herzliya, IL 46728 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-08 |
| Decision Date | 2004-06-17 |
| Summary: | summary |