The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Wagner Revision Stem (modification).
Device ID | K953689 |
510k Number | K953689 |
Device Name: | WAGNER REVISION STEM (MODIFICATION) |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Barry J Hassett |
Correspondent | Barry J Hassett INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-31 |
Decision Date | 1995-11-29 |