Plexur M
FDA 510(k) K081227 · Osteotech, Inc.
510(k) numberK081227
Submission
- Device name
- Plexur M
- Applicant
- Osteotech, Inc.
Eatontown, NJ, US - Received
- April 30, 2008
- Decision date
- July 22, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…MQV · Traditional | 10/16/2008SE |
| 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 |
| K043209 | Viagraf DBM PasteMBP · Traditional | 12/05/2005SE |
| K053080 | Graftcage AcxMQP · Traditional | 12/01/2005SE |
| K042707 | Grafton Plus DBM PasteNUN · Traditional | 11/30/2005SE |
Questions and answers
When was Plexur M cleared by the FDA?
Plexur M (K081227) received a 510(k) decision of Substantially Equivalent on July 22, 2008, 83 days after the submission was received.
What is the product code of K081227?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.