The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Profix Plus Tibial Insert, Profix Ps Plus Tibial Insert, Profix P/s Tibial Insert.
Device ID | K963255 |
510k Number | K963255 |
Device Name: | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116 |
Contact | Thomas L Craig |
Correspondent | Thomas L Craig SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 E. BROOKS RD. Memphis, TN 38116 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-19 |
Decision Date | 1997-01-02 |
Summary: | summary |