The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Ria System (expanded Indications).
| Device ID | K111437 |
| 510k Number | K111437 |
| Device Name: | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) |
| Classification | Reamer |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Angela F Lassandro |
| Correspondent | Angela F Lassandro SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-24 |
| Decision Date | 2011-08-10 |
| Summary: | summary |