The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Cementless Zweymueller Hip Endoprothes.
Device ID | K822979 |
510k Number | K822979 |
Device Name: | CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | ALLO PRO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-08 |
Decision Date | 1983-01-14 |