Eovia Calcium Phosphate Ceramic
FDA 510(k) K040514 · Ortho Tec, LLC
510(k) numberK040514
Submission
- Device name
- Eovia Calcium Phosphate Ceramic
- Applicant
- Ortho Tec, LLC
California, CA, US - Received
- February 27, 2004
- Decision date
- May 3, 2004
- 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 |
|---|---|---|
| K040346 | Modification to Oria Top Clip SystemMNI · Special | 03/12/2004SE |
| K030958 | Oria Spinal System, Domino and Tube ConnectorsMNI · Traditional | 11/20/2003SE |
| K031471 | Oria Spinal Clip System, Lateral Intermediate Connector, Model AL01KWP · Traditional | 10/10/2003SE |
| K023884 | Modification Oria Spinal SystemKWP · Traditional | 08/20/2003SE |
| K023378 | Oria ClarisMNH · Traditional | 06/27/2003SE |
| K031452 | Oria Spinal Clip System, Sacral Connector, Models CA03 and AO03KWP · Special | 06/18/2003SE |
| K030500 | Oria ZenithKWQ · Special | 03/20/2003SE |
| K023377 | Oria Cervical PlatesKWQ · Traditional | 03/04/2003SE |
| K030253 | Oria Spinal Clip System, Lengthened Lateral Connector, Model AL06KWP · Special | 02/21/2003SE |
| K030252 | Oria Spinal Clip System Extended Omniaxial Connectors (CO05 & CO07)KWP · Special | 02/21/2003SE |
Questions and answers
When was Eovia Calcium Phosphate Ceramic cleared by the FDA?
Eovia Calcium Phosphate Ceramic (K040514) received a 510(k) decision of Substantially Equivalent on May 3, 2004, 66 days after the submission was received.
What is the product code of K040514?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.