The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Endo-model Knee System, Femoral Segments (augments), Uhmwpe.
Device ID | K211768 |
510k Number | K211768 |
Device Name: | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE |
Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
Contact | Stefanie Fuchs |
Correspondent | Terry Sheridan Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
Product Code | KRO |
Subsequent Product Code | JDI |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-08 |
Decision Date | 2021-06-30 |