The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Compression Hip Screw System, Intramedullary Hip Screw System.
Device ID | K993289 |
510k Number | K993289 |
Device Name: | SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Janet Johnson Green |
Correspondent | Janet Johnson Green SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-01 |
Decision Date | 1999-12-20 |
Summary: | summary |