Alphamet L T D

FDA Filings

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

FDA Registration(s)
Registration Number3016250463
FEI Number3016250463
NameElaine Duncan
Owner & OperatorAlphaMet Ltd.
Contact Address3 Hadolev st.
Bar-Lev High-Tech Park IL-NOTA 2015600 IL
Official Correspondent
  • Rafi Herzog
  • 972-5-8769250-x
US Agent
Importing Logistics Registration
ImporterGenesis Ortho Partners
Address307 S. 2nd st.
Garrett, IN 46738 UNITED STATES
Email AddressBcoburn@genorthopartners.com
Phone1 260 4382198
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address415 Valley View Trail
Houlton, WI 54082 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
ALPHAMET LTD
 CyclaPlex Implant IM-91012020-02-20
ALPHAMET LTD
 CyclaPlex Screwdriver SD-92212020-02-20
ALPHAMET LTD
 CyclaPlex Drill Guide DG-92012020-02-20
ALPHAMET LTD
 CyclaPlex Drill Bits 1.8-3.0 DB-92432020-02-20
ALPHAMET LTD
 CyclaPlex Correction System Instruments Case Set IC-98022020-02-20
ALPHAMET LTD
 CyclaPlex Correction System Instruments Case IC-98012020-02-20
Elaine Duncan [AlphaMet Ltd.]
CyclaPlex Correction System2019-12-16

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