The following data is part of a premarket notification filed by Plus Orthopedics with the FDA for Rt-plus Solution & Rt-plus Modular Solution Knee.
Device ID | K023667 |
510k Number | K023667 |
Device Name: | RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
Contact | J.d. Webb |
Correspondent | J.d. Webb PLUS ORTHOPEDICS 1001 OAKWOOD BLVD. Round Rock, TX 78681 -2700 |
Product Code | KRO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-31 |
Decision Date | 2002-12-24 |
Summary: | summary |