The following data is part of a premarket notification filed by Morley Research Consortium with the FDA for Xd880a Ultrasonic Osteotomy Surgical System.
| Device ID | K172464 |
| 510k Number | K172464 |
| Device Name: | XD880A Ultrasonic Osteotomy Surgical System |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | Morley Research Consortium Four Concourse Parkway Suite 215 Atlanta, GA 30328 |
| Contact | Suzan Davis |
| Correspondent | Suzan Davis Morley Research Consortium Four Concourse Parkway Suite 215 Atlanta, GA 30328 |
| Product Code | JDX |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-14 |
| Decision Date | 2018-04-24 |
| Summary: | summary |