The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Reflection 3-hole Shell With Asymmetric Porous Coating.
Device ID | K060630 |
510k Number | K060630 |
Device Name: | REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Katie Logerot |
Correspondent | Katie Logerot SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | LPH |
Subsequent Product Code | JDI |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
Subsequent Product Code | MBL |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-09 |
Decision Date | 2006-06-14 |
Summary: | summary |