The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Weber-stuhmer Hip Prosthesis Stem.
Device ID | K841391 |
510k Number | K841391 |
Device Name: | WEBER-STUHMER HIP PROSTHESIS STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | ALLO PRO CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-03 |
Decision Date | 1984-04-13 |