Stimulan - Calcium Sulfate Bone Void Filler Kit
FDA 510(k) K003954 · Biocomposites, Ltd.
510(k) numberK003954
Submission
- Device name
- Stimulan - Calcium Sulfate Bone Void Filler Kit
- Applicant
- Biocomposites, Ltd.
Stoke On Trent, GB - Received
- December 21, 2000
- Decision date
- July 12, 2001
- 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 |
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| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
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| 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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| K250521 | NanoBone® SBX Putty ; NanoBone® QDMQV · Traditional | 04/07/2025SE |
| K212721 | Genex Bone Graft SubstituteMQV · Traditional | 02/04/2022SE |
| K141830 | Stimulan Kit, Stimulan Rapid CureMQV · Traditional | 01/23/2015SE |
| K082381 | GenexMQV · Traditional | 11/14/2008SE |
| K082383 | Fortoss VitalLYC · Special | 09/05/2008SE |
| K073341 | Genex PuttyMQV · Traditional | 07/09/2008SE |
| K081428 | Modification to Doubleplay Suture AnchorHWC · Special | 06/20/2008SE |
| K072127 | DominatorHWC · Special | 08/31/2007SE |
Questions and answers
When was Stimulan - Calcium Sulfate Bone Void Filler Kit cleared by the FDA?
Stimulan - Calcium Sulfate Bone Void Filler Kit (K003954) received a 510(k) decision of Substantially Equivalent on July 12, 2001, 203 days after the submission was received.
What is the product code of K003954?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.