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 |