The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Protek Acetabular Roof Reinforcement Ring.
Device ID | K953578 |
510k Number | K953578 |
Device Name: | PROTEK ACETABULAR ROOF REINFORCEMENT RING |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Joann Ringer-kuhne |
Correspondent | Joann Ringer-kuhne INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-01 |
Decision Date | 1995-10-30 |