Company · US

Osteotech, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2008. Name variants (Inc, Corp, punctuation) are merged.

24510(k) clearances (0 in 12 months)

14recalls (0 in 12 months)

14recalls that name a 510(k)

Product codes

Code	Device	Records
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	18
KWP	Appliance, Fixation, Spinal Interlaminal	5
MQP	Spinal Vertebral Body Replacement Device	4
MQV	Filler, Bone Void, Calcium Compound	4
NUN	Bone Grafting Material, Human Source	2
HWC	Screw, Fixation, Bone	1
KIT	Media And Components, Synthetic Cell And Tissue Culture	1
LRP	Tray, Surgical	1
LYC	Bone Grafting Material, Synthetic	1
MNH	Orthosis, Spondylolisthesis Spinal Fixation	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Oct 16, 2008	K082615	GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES Osteotech, Inc.	MQV
Jul 22, 2008	K081227	PLEXUR M Osteotech, Inc.	MQV
Apr 21, 2008	K080511	PLEXUR-P Osteotech, Inc.	MQV
Mar 3, 2008	K073405	PLEXUR M Osteotech, Inc.	MQV
Feb 7, 2007	K061982	PLEXUR P Osteotech, Inc.	MBP
Jan 3, 2006	K051188	GRAFTON DBM Osteotech, Inc.	NUN
Dec 16, 2005	K051781	GRAFTCAGE TLX Osteotech, Inc.	MQP
Dec 16, 2005	K051195	GRAFTON DBM Osteotech, Inc.	MBP
Dec 5, 2005	K043209	VIAGRAF DBM PASTE Osteotech, Inc.	MBP
Dec 1, 2005	K053080	GRAFTCAGE ACX Osteotech, Inc.	MQP
Nov 30, 2005	K042707	GRAFTON PLUS DBM PASTE Osteotech, Inc.	NUN
Nov 23, 2005	K043048	GRAFTON PLUS DBM PASTE Osteotech, Inc.	MBP
Oct 16, 2001	K012254	VBR Osteotech, Inc.	MQP
Jan 4, 2001	K003155	VERTEBRAL BODY REPLACEMENT Osteotech, Inc.	MQP
Nov 24, 2000	K003384	VERSALINK TITANIUM ROD-TO-ROD COUPLERS Osteotech, Inc.	MNH
Nov 19, 1999	K992885	VERSALOK LOW BACK FIXATION SYSTEM Osteotech, Inc.	KWP
Jul 23, 1999	K991586	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc.	KWP
Jan 8, 1998	K973868	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc.	KWP
Jun 18, 1997	K971289	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc.	KWP
Feb 9, 1996	K955173	SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM) Osteotech, Inc.	KWP
Jun 22, 1995	K950652	OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS Osteotech, Inc.	HWC
May 31, 1995	K951811	OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK Osteotech, Inc.	LRP
Oct 13, 1988	K883065	ALLOPREP SYSTEM Osteotech, Inc.	KIT
Oct 7, 1985	K852199	OSTEOGRAF 2040 OSTEOGRAF 4060 Osteotech, Inc.	LYC

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Oct 18, 2012	Osteotech Inc Optimum Expanse S Multiple sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Optimum Expanse R Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intende Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Large Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone mat Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Orthoblend Small Defect Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matr Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Matrix Strips Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) a Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Matrix PLF Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allo Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Crunch Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM A-Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograf Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Flex Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Gel Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. Terminated	MBP	K042707 K043048 +2
Oct 18, 2012	Osteotech Inc Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft Terminated	MBP	K042707 K043048 +2
Jan 11, 2012	Osteotech Inc Grafton DBM A-Flex; Unit Size 60 mm diam; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts Terminated	MBP	K051195
Jan 11, 2012	Osteotech Inc Grafton DBM Flex; Unit Size 5x5 cm; 1ea Container: Foil Pouch with Tyvek pouch Fracture repair, bridge bone gaps or fragments, use with strut grafts Terminated	MBP	K051195

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