Amend Surgical Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012161787
• FEI Number: 3012161787
• Name: AMEND SURGICAL, INC.
• Owner & Operator: Amend Surgical, Inc.
• Contact Address: 14000 NW 126th Ter ; Alachua FL 32615 US
• Official Correspondent:
  • Robby Lane
  • x-352-2264988-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 14000 NW 126th Ter ; Alachua, FL 32615 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00858686006096 AMEND SURGICAL, INC.	NanoFUSE Bioactive Strip ASI209-20	2019-07-24
GUDID 00858686006089 AMEND SURGICAL, INC.	NanoFUSE Bioactive Strip ASI209-10	2019-07-24
PMN K161996 | MQV AMEND SURGICAL, INC.	NanoFUSE Bioactive Strip	2019-06-20
GUDID 00858686006072 AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty BGP001-10	2018-07-06
GUDID 00858686006065 AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty - 5.0 cc BGP001-05	2018-07-06
GUDID 00858686006058 AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty - 2.0 cc BGP001-02	2018-07-06
GUDID 00858686006041 AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty BGP001-01	2018-07-06
GUDID 00858686006034 AMEND SURGICAL, INC.	NanoFuse Bioactive Matrix - 1.0 cc NAN109-01	2018-07-06
GUDID 00858686006027 AMEND SURGICAL, INC.	NanoFuse Bioactive Matrix - 10.0 cc NAN109-10	2018-07-06
GUDID 00858686006010 AMEND SURGICAL, INC.	NanoFuse Bioactive Matrix - 5.0 cc NAN109-05	2018-07-06
GUDID 00858686006003 AMEND SURGICAL, INC.	NanoFuse Bioactive Matrix - 2.0 cc NAN109-02	2018-07-06
PMN K161996 Amend Surgical, Inc.	0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE	2017-02-16
PMN K142104 | MQV AMEND SURGICAL, INC.	NanoFUSE Bioactive Matrix	2016-01-25
PMN K142104 | MQV AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty	2016-01-25
PMN K142104 | MBP AMEND SURGICAL, INC.	NanoFUSE Bioactive Matrix	2016-01-25
PMN K142104 | MBP AMEND SURGICAL, INC.	Bio V BP Bioactive Glass with DBM Putty	2016-01-25

Related Finance Registrations

NCAGE Code	88YE2	AMEND SURGICAL, INC.!DBA AMEND SURGICAL
CAGE Code	88YE2	AMEND SURGICAL, INC. AMEND SURGICAL
S.A.M. Registration	88YE2 [80131031]	AMEND SURGICAL, INC. AMEND SURGICAL
S.A.M. Registration	88YE2 [80131031]	AMEND SURGICAL, INC. AMEND SURGICAL