The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Synergy Uhd4 System.
| Device ID | K153218 |
| 510k Number | K153218 |
| Device Name: | Arthrex Synergy UHD4 System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, OH 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers ARTHREX, INC. 1370 CREEKSIDE BOULEVARD Naples, OH 34108 -1945 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-05 |
| Decision Date | 2016-02-12 |
| Summary: | summary |