Callos
FDA 510(k) K030554 · Skeletal Kinetics, LLC
510(k) numberK030554
Submission
- Device name
- Callos
- Applicant
- Skeletal Kinetics, LLC
Washington, DC, US - Received
- February 21, 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 |
|---|---|---|
| K162864 | OsteoVation ImpactGXP · Traditional | 01/13/2017SE |
| K132211 | Skaffold NMX Bone Void FillerMQV · Traditional | 08/04/2014SE |
| K120354 | Beta-Tcp GranulesMQV · Traditional | 03/21/2013SE |
| K112383 | Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerMQV · Traditional | 02/07/2012SE |
| K111538 | Skaffold CisMTJ · Traditional | 10/25/2011SE |
| K100986 | Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationMQV · Traditional | 07/20/2010SE |
| K051784 | Osteovation CMF Bone Void FillerGXP · Special | 07/20/2005SE |
| K051123 | Callos Impact and Inject Bone Void FillerMQV · Special | 06/03/2005SE |
| K042072 | Callos CMF Bone Void FillerGXP · Traditional | 09/16/2004SE |
Questions and answers
When was Callos cleared by the FDA?
Callos (K030554) received a 510(k) decision of Substantially Equivalent on May 20, 2003, 88 days after the submission was received.
What is the product code of K030554?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.