Implantcast

FDA Filings

This page includes the latest FDA filings for Implantcast. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3012523063

FEI Number

3012523063

Name

Andy Hewes

Owner & Operator

implantcast

Contact Address

Lueneburger Schanze 26
Buxtehude DE-NI Niedersachsen 21614 DE

Official Correspondent

Juliane Hoeppner
49-416-1744-135

US Agent

Andy Hewes
IMPLANTCAST AMERICA, LLC
214 2337717
AHewes@exlor.com

Importing Logistics Registration

Importer	implantcast North America
Address	13465 Midway Rd, Ste 310 Dallas, TX 75244 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

13465 Midway Rd Ste 310
Dallas, TX 75244 US

Establishment Type

Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K191569 \| MEH Andy Hewes [implantcast]	ic-Bipolar Head System	2019-08-29
PMN K191569 \| LZO Andy Hewes [implantcast]	ic-Bipolar Head System	2019-08-29
PMN K191569 \| KWY Andy Hewes [implantcast]	ic-Bipolar Head System	2019-08-29
PMN K181778 \| MEH Andy Hewes [implantcast]	MUTARS Proximal Femur Replacement System	2019-03-26
PMN K181778 \| LZO Andy Hewes [implantcast]	MUTARS Proximal Femur Replacement System	2019-03-26
PMN K181778 \| KWY Andy Hewes [implantcast]	MUTARS Proximal Femur Replacement System	2019-03-26
HXC Andy Hewes [implantcast]	MUTARS torque wrench M8 M10	2019-03-26
HXC Andy Hewes [implantcast]	MUTARS socket wrench	2019-03-26
HXC Andy Hewes [implantcast]	MUTARS engineers wrench SW 24	2019-03-26
PMN K163577 \| LZO Andy Hewes [implantcast]	Ecofit Hip System	2017-10-04

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