The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Tillman Hip Resurfacing Replacemt Pros..
Device ID | K792200 |
510k Number | K792200 |
Device Name: | TILLMAN HIP RESURFACING REPLACEMT PROS. |
Classification | Prosthesis, Hip, Femoral, Resurfacing |
Applicant | WALDEMAR LINK GMBH & CO. KG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXA |
CFR Regulation Number | 888.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-11-01 |
Decision Date | 1979-12-05 |