The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Modification To Smith & Nephew Intramedullary Hip Screw.
Device ID | K040656 |
510k Number | K040656 |
Device Name: | MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW |
Classification | Screw, Fixation, Bone |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Janet Akil |
Correspondent | Janet Akil SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-03-12 |
Decision Date | 2004-05-25 |
Summary: | summary |