The following data is part of a premarket notification filed by Paragon 28, Inc with the FDA for Maven™ Patient-specific Instrumentation.
Device ID | K223227 |
510k Number | K223227 |
Device Name: | MAVEN™ Patient-Specific Instrumentation |
Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
Applicant | Paragon 28, Inc 14445 Grasslands Drive Englewood, CO 80112 |
Contact | Greg Kowalczyk |
Correspondent | Jan Triani Triani Consulting, LLC 14445 Grasslands Drive Englewood, CO 80112 |
Product Code | HSN |
CFR Regulation Number | 888.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-10-18 |
Decision Date | 2022-11-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MAVEN 98549383 not registered Live/Pending |
Densitas Inc. 2024-05-14 |
![]() MAVEN 98232747 not registered Live/Pending |
Normark Corporation 2023-10-20 |
![]() MAVEN 98189448 not registered Live/Pending |
ASSA ABLOY Americas Residential Inc. 2023-09-20 |
![]() MAVEN 98152106 not registered Live/Pending |
Maven Clinic Co. 2023-08-26 |
![]() MAVEN 98105648 not registered Live/Pending |
Maven Coffee Company LLC 2023-07-27 |
![]() MAVEN 97920237 not registered Live/Pending |
SRAM, LLC 2023-05-04 |
![]() MAVEN 97919063 not registered Live/Pending |
Maven Research, Inc. 2023-05-03 |
![]() MAVEN 97841976 not registered Live/Pending |
Helena Holding Company 2023-03-16 |
![]() MAVEN 97584983 not registered Live/Pending |
908 Devices Inc. 2022-09-09 |
![]() MAVEN 97541233 not registered Live/Pending |
Michael The Maven 2022-08-09 |
![]() MAVEN 97211491 not registered Live/Pending |
Maven IP, PA 2022-01-10 |
![]() MAVEN 90898714 not registered Live/Pending |
Maven Wireless Sweden AB 2021-08-24 |