The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Reflection Acetabular Component.
Device ID | K932755 |
510k Number | K932755 |
Device Name: | REFLECTION ACETABULAR COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Thomas Craig |
Correspondent | Thomas Craig SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-21 |
Decision Date | 1994-05-06 |