The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Journey Unicondylar Tibial Baseplates.
Device ID | K102069 |
510k Number | K102069 |
Device Name: | JOURNEY UNICONDYLAR TIBIAL BASEPLATES |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Contact | Gino Rouss |
Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116 |
Product Code | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-07-23 |
Decision Date | 2010-10-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00885556088395 | K102069 | 000 |
00885556087893 | K102069 | 000 |
00885556087947 | K102069 | 000 |
00885556087992 | K102069 | 000 |
00885556088043 | K102069 | 000 |
00885556088098 | K102069 | 000 |
00885556088142 | K102069 | 000 |
00885556088197 | K102069 | 000 |
00885556088241 | K102069 | 000 |
00885556088296 | K102069 | 000 |
00885556088340 | K102069 | 000 |
00885556087848 | K102069 | 000 |