Calcium Phosphate Granular Bone Void Filler
FDA 510(k) K011531 · Biomet, Inc.
510(k) numberK011531
Submission
- Device name
- Calcium Phosphate Granular Bone Void Filler
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- May 17, 2001
- Decision date
- September 6, 2002
- 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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|---|---|---|---|
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| 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 |
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| 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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Questions and answers
When was Calcium Phosphate Granular Bone Void Filler cleared by the FDA?
Calcium Phosphate Granular Bone Void Filler (K011531) received a 510(k) decision of Substantially Equivalent on September 6, 2002, 477 days after the submission was received.
What is the product code of K011531?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.