The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Burch/schneider Reinforcement Cage.
Device ID | K960678 |
510k Number | K960678 |
Device Name: | BURCH/SCHNEIDER REINFORCEMENT CAGE |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Sam Mirza |
Correspondent | Sam Mirza 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 | 1996-02-16 |
Decision Date | 1996-05-03 |
Summary: | summary |