Sigmagraft Inc

FDA Filings

This page includes the latest FDA filings for Sigmagraft 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: 3009598981
• FEI Number: 3009598981
• Name: SIGMAGRAFT, INC.
• Owner & Operator: SigmaGraft, Inc.
• Contact Address: 575 Sally Place ; Fullerton CA 92831 US
• Official Correspondent:
  • Dae Kyu Chang
  • x-714-5250114-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 575 Sally Pl ; Fullerton, CA 92831 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00852072007551 SIGMAGRAFT, INC.	InterCollagen Guide	2023-09-29
GUDID 00852072007544 SIGMAGRAFT, INC.	InterCollagen Guide	2023-09-29
GUDID 00852072007537 SIGMAGRAFT, INC.	InterCollagen Guide	2023-09-29
GUDID 00852072007520 SIGMAGRAFT, INC.	InterCollagen Guide	2023-09-29
GUDID 00852072007506 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007490 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007483 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007476 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007469 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007452 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007445 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007438 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007421 SIGMAGRAFT, INC.	InterOss Collagen	2023-05-23
GUDID 00852072007650 SIGMAGRAFT, INC.	Puraxen+	2023-03-09
GUDID 00852072007643 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007636 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007629 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007612 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007605 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007599 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007582 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007575 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007568 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007209 SIGMAGRAFT, INC.	PuraXen+	2023-03-09
GUDID 00852072007148 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007131 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007124 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007117 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007100 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007094 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007087 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007070 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007063 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007056 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007049 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007032 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007025 SIGMAGRAFT, INC.	InterOss®	2018-10-03
GUDID 00852072007018 SIGMAGRAFT, INC.	InterOss®	2018-10-03
PMN K151209 | NPM SIGMAGRAFT, INC.	Mega-Oss BovineTM	2015-11-16
PMN K151209 | NPM SIGMAGRAFT, INC.	Maxxeus Dental Xenograft Particulates	2015-11-16
PMN K151209 | NPM SIGMAGRAFT, INC.	InterOss	2015-11-16
PMN K151209 SigmaGraft, Inc	InterOss	2015-11-06

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020012350432	Pusan,South Korea -> Los Angeles, California	VIALS	1 PKG
2019101534873	Pusan,South Korea -> Long Beach, California	LABORATORY HYGIENIC OR PHARMACEUTICAL GLASSWA RE VIALS	2 PKG
2019081436562	Tsingtao,China (Mainland) -> Los Angeles, California	GLASS VIAL RUBBER STOPPER PLASTIC CAP	38 PKG
2018110954245	Pusan,South Korea -> Long Beach, California	TITANUM BAR 8108.90-9000	4 PKG
2018062934131	Shanghai ,China (Mainland) -> Los Angeles, California	SCREW AND BARREL	1 PKG
2018062838331	Shanghai ,China (Mainland) -> Los Angeles, California	SCREW AND BARREL	1 PKG
2018040553889	Pusan,South Korea -> Long Beach, California	BLISTER HS CODE 392329	2 PKG