Biofill Bone Void Filler
FDA 510(k) K040454 · Scient'X
510(k) numberK040454
Submission
- Device name
- Biofill Bone Void Filler
- Applicant
- Scient'X
Round Rock, TX, US - Received
- February 23, 2004
- Decision date
- May 7, 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
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|---|---|---|---|
| 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 |
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| K052367 | Scient'X Cement RestrictorJDK · Traditional | 10/05/2005SESU |
| K050348 | Co Vertebral Body ReplacementMQP · Special | 05/27/2005SE |
| K051063 | Polyaxial Hemispherical Spinal ScrewsMNI · Special | 05/23/2005SE |
| K043001 | MX Polyaxial Pedicle ScrewMNH · Special | 12/01/2004SE |
| K042964 | MX Monoaxial Pedicle ScrewMNH · Special | 11/22/2004SE |
| K042317 | Cervical PlateKWQ · Special | 09/24/2004SE |
| K040747 | Aladyn Rigid Spine PlateMNH · Special | 06/17/2004SE |
Questions and answers
When was Biofill Bone Void Filler cleared by the FDA?
Biofill Bone Void Filler (K040454) received a 510(k) decision of Substantially Equivalent on May 7, 2004, 74 days after the submission was received.
What is the product code of K040454?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.