Viagraf DBM Paste
FDA 510(k) K043209 · Osteotech, Inc.
510(k) numberK043209
Submission
- Device name
- Viagraf DBM Paste
- Applicant
- Osteotech, Inc.
Eatontown, NJ, US - Received
- November 19, 2004
- Decision date
- December 5, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBP – Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242799 | PliaFX FloMBP · Traditional | Lifenet Health | 11/21/2024SE |
| K143547 | Vivorte Trabexus EBMBP · Special | Vivorte, Inc. | 01/14/2015SE |
| K130703 | Vivorte BVFMBP · Traditional | Vivorte, Inc. | 09/12/2013SE |
| K130498 | Osteoselect Demineralized Bone Matrix PuttyMBP · Traditional | Bacterin International, Inc. | 05/31/2013SE |
| K122513 | Cleared Under Grafton II EdbmMBP · Traditional | Medtronic Sofamor Danek, Inc. | 03/06/2013SE |
| K113728 | Surfuse Gel and Putty, Exfuse Gel and PuttyMBP · Traditional | Hans Biomed Corp. | 11/15/2012SE |
| K103742 | Accell EVO3 (Formerly Accell A2I)MBP · Traditional | Integra Life Sciences | 03/17/2011SE |
| K091193 | Accell EVO3CMBP · Traditional | Isotis Orthobiologics, Inc. | 08/10/2009SE |
| K080399 | DBX Demineralized Bone Matrix Putty, DBX Demineralized Bone Matrix PasteMBP · Traditional | Musculoskeletal Transplant Foundation | 10/10/2008SE |
| K081817 | Accell Tbm-RMBP · Traditional | Isotis Orthobiologics, Inc. | 09/24/2008SE |
More from Isotis Orthobiologics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…MQV · Traditional | 10/16/2008SE |
| K081227 | Plexur MMQV · Traditional | 07/22/2008SE |
| K080511 | Plexur-PMQV · Traditional | 04/21/2008SE |
| K073405 | Plexur MMQV · Traditional | 03/03/2008SE |
| K061982 | Plexur PMBP · Traditional | 02/07/2007SE |
| K051188 | Grafton DBMNUN · Traditional | 01/03/2006SE |
| K051781 | Graftcage TLXMQP · Traditional | 12/16/2005SE |
| K051195 | Grafton DBMMBP · Traditional | 12/16/2005SE |
| K053080 | Graftcage AcxMQP · Traditional | 12/01/2005SE |
| K042707 | Grafton Plus DBM PasteNUN · Traditional | 11/30/2005SE |
Questions and answers
When was Viagraf DBM Paste cleared by the FDA?
Viagraf DBM Paste (K043209) received a 510(k) decision of Substantially Equivalent on December 5, 2005, 381 days after the submission was received.
What is the product code of K043209?
The FDA product code is MBP – Filler, Bone Void, Osteoinduction (W/O Human Growth Factor), a Class II (moderate risk) device regulated under 21 CFR 888.3045.