Data / Medical devices / United States / Osteotech, Inc.
Osteotech, Inc.: FDA-registered device maker in Eatontown, NJ, United States, 9 510(k) clearances
Osteotech, Inc. is registered with the FDA (registration 2249915) in Eatontown, NJ, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 7, 2015. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2249915
- FEI number
- 3002600221
- Address
- 201 Industrial Way West, Eatontown, NJ, United States, 07724
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- November 21, 2011
- Registered through
- 2026
- Brand names listed
- Graft Delivery Device with Integrated Stylet Syringe, Piston, Grafton DBM, Grafton DBM Paste, Grafton DBM Plus, Grafton II eDBM, MagniFuse, MagniFuse Bone Graft, Magnifuse II Bone Graft and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bone Grafting Material, Human Source | NUN | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| March 6, 2013 | K122513 | CLEARED UNDER GRAFTON II EDBM | MBP | Substantially Equivalent | Medtronic Sofamor Danek, Inc. | accessdata.fda.gov |
| October 16, 2008 | K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | MQV | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| April 21, 2008 | K080511 | PLEXUR-P | MQV | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| February 7, 2007 | K061982 | PLEXUR P | MBP | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| January 3, 2006 | K051188 | GRAFTON DBM | NUN | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| December 16, 2005 | K051195 | GRAFTON DBM | MBP | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| November 30, 2005 | K042707 | GRAFTON PLUS DBM PASTE | NUN | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
| November 23, 2005 | K043048 | GRAFTON PLUS DBM PASTE | MBP | Substantially Equivalent | Osteotech, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2012 | 62569 | Class II | Terminated | 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. It is intended for | Multiple lots of GRAFTON and XPANSE, which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised. | accessdata.fda.gov |
| August 8, 2011 | 60263 | Not yet classified | Terminated | 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 | Aseptic conditions during the production of these products may have been compromised. | accessdata.fda.gov |
Compare with other makers
- All makers of Bone Grafting Material, Human Source
- All makers of Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Syringe, Piston
Updated July 7, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.