Osteotech Inc

FDA Filings

This page includes the latest FDA filings for Osteotech 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: 2249915
• FEI Number: 3002600221
• Name: OSTEOTECH, INC.
• Owner & Operator: MEDTRONIC INC.
• Contact Address: 710 Medtronic Pkwy. ; Minneapolis MN 55432 US
• Official Correspondent:
  • CHRISTINE - BOES
  • x-763-5260396-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 201 Industrial Way West ; EATONTOWN, NJ 07724 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K122513 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Magnifuse II Bone Graft	2014-01-31
PMN K122513 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Magnifuse II Bone Graft	2014-01-31
PMN K053098 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM	2012-12-10
PMN K053098 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM Putty	2012-12-10
PMN K053098 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM Gel	2012-12-10
PMN K053098 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM	2012-12-10
PMN K053098 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM Putty	2012-12-10
PMN K053098 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Optium DBM Gel	2012-12-10
PMN K082615 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	MagniFuse	2011-11-22
PMN K082615 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	MagniFuse Bone Graft	2011-11-22
PMN K082615 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton II eDBM	2011-11-22
PMN K081227 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M	2011-11-22
PMN K081227 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M Heater Accessory	2011-11-22
PMN K081227 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M Biocomposite	2011-11-22
PMN K073405 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M	2011-11-22
PMN K073405 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M Heater Accessory	2011-11-22
PMN K073405 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur M Biocomposite	2011-11-22
PMN K061982 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur P	2011-11-22
PMN K061982 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur P	2011-11-22
PMN K080511 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Plexur P	2011-11-21
PMN K051195 | MQV OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM	2011-11-21
PMN K051195 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM	2011-11-21
PMN K051188 | NUN OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM	2011-11-21
PMN K043048 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM Plus	2011-11-21
PMN K043048 | MBP OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM Paste	2011-11-21
PMN K042707 | NUN OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM Plus	2011-11-21
PMN K042707 | NUN OSTEOTECH, INC. [MEDTRONIC INC.]	Grafton DBM Paste	2011-11-21
PMN K082615 OSTEOTECH INC	GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES	2008-10-16
PMN K081227 OSTEOTECH, INC.	PLEXUR M	2008-07-22
PMN K080511 OSTEOTECH, INC.	PLEXUR-P	2008-04-21
PMN K073405 OSTEOTECH, INC.	PLEXUR M	2008-03-03
PMN K061982 OSTEOTECH, INC.	PLEXUR P	2007-02-07
PMN K051188 OSTEOTECH, INC.	GRAFTON DBM	2006-01-03
PMN K051781 OSTEOTECH, INC.	GRAFTCAGE TLX	2005-12-16
PMN K051195 OSTEOTECH, INC.	GRAFTON DBM	2005-12-16
PMN K043209 OSTEOTECH, INC.	VIAGRAF DBM PASTE	2005-12-05
PMN K053080 OSTEOTECH, INC.	GRAFTCAGE ACX	2005-12-01
PMN K042707 OSTEOTECH, INC.	GRAFTON PLUS DBM PASTE	2005-11-30
PMN K043048 OSTEOTECH, INC.	GRAFTON PLUS DBM PASTE	2005-11-23
PMN K012254 OSTEOTECH, INC.	VBR	2001-10-16
PMN K003155 OSTEOTECH, INC.	VERTEBRAL BODY REPLACEMENT	2001-01-04
PMN K003384 OSTEOTECH, INC.	VERSALINK TITANIUM ROD-TO-ROD COUPLERS	2000-11-24
PMN K992885 OSTEOTECH, INC.	VERSALOK LOW BACK FIXATION SYSTEM	1999-11-19
PMN K991586 OSTEOTECH, INC.	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	1999-07-23
PMN K973868 OSTEOTECH, INC.	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	1998-01-08
PMN K971289 OSTEOTECH, INC.	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	1997-06-18
PMN K955173 OSTEOTECH, INC.	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)	1996-02-09
PMN K950652 OSTEOTECH, INC.	OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS	1995-06-22
PMN K951811 OSTEOTECH, INC.	OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK	1995-05-31
PMN K883065 OSTEOTECH, INC.	ALLOPREP SYSTEM	1988-10-13
PMN K852199 OSTEOTECH, INC.	OSTEOGRAF 2040 OSTEOGRAF 4060	1985-10-07

Related Finance Registrations

NCAGE Code	0D2U7	OSTEOTECH INC.
CAGE Code	0D2U7	OSTEOTECH, INC.
DUNS	157384306	OSTEOTECH, INC.
SEC	0000874734	OSTEOTECH INC of DELAWARE