Ossatura BCP Bone Void Filler
FDA 510(k) K030131 · Isotis NV
510(k) numberK030131
Submission
- Device name
- Ossatura BCP Bone Void Filler
- Applicant
- Isotis NV
North Attleboro, MA, US - Received
- January 14, 2003
- Decision date
- May 20, 2003
- 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 |
|---|---|---|
| K061880 | Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CCMQV · Traditional | 08/15/2007SE |
| K060332 | Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyNUN · Traditional | 03/29/2006SE |
| K060306 | Accell Connexus Demineralized Bone Matrix PuttyNUN · Traditional | 03/27/2006SE |
| K031813 | Ossatura DentalLYC · Traditional | 08/20/2004SE |
| K041344 | Open Bore SyringeFMF · Abbreviated | 07/16/2004SE |
| K010840 | SynplugLZN · Special | 04/20/2001SE |
| K000587 | Shuttle StopLZN · Traditional | 05/04/2000SE |
Questions and answers
When was Ossatura BCP Bone Void Filler cleared by the FDA?
Ossatura BCP Bone Void Filler (K030131) received a 510(k) decision of Substantially Equivalent on May 20, 2003, 126 days after the submission was received.
What is the product code of K030131?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.