The following data is part of a premarket notification filed by Limacorporate S.p.a with the FDA for Amf Revision Tt Cones.
Device ID | K200653 |
510k Number | K200653 |
Device Name: | AMF Revision TT Cones |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | LimaCorporate S.p.A Via Nazionale 52 Villanova Di San Daniele Del Friuli, IT 33038 |
Contact | Roberto Gabetta |
Correspondent | Lacey Harbour Lima USA Inc 2001 NE Green Oaks Blvd. Ste.100 Arlington, TX 76006 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-03-12 |
Decision Date | 2020-05-07 |