Callos CMF Bone Void Filler
FDA 510(k) K042072 · Skeletal Kinetics, LLC
510(k) numberK042072
Submission
- Device name
- Callos CMF Bone Void Filler
- Applicant
- Skeletal Kinetics, LLC
Cupertino, CA, US - Received
- August 2, 2004
- Decision date
- September 16, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251959 | TnR Cranial ImplantGXP · Traditional | T&R BIOFAB CO., Ltd. | 07/30/2026SE |
| K261265 | Permatage XT Settable Bone PuttyGXP · Special | Orthocon, Inc. | 06/15/2026SE |
| K253732 | Permatage Flowable, Settable Bone PasteGXP · Traditional | Orthocon, Inc. | 03/13/2026SE |
| K253854 | MONTAGE XT Cranial CementGXP · Special | Orthocon, Inc. | 01/02/2026SE |
| K241027 | Permatage Settable Bone PuttyGXP · Traditional | Orthocon, Inc. | 09/26/2024SE |
| K232771 | Montage Flowable Settable, Resorbable Bone PasteGXP · Traditional | Orthocon, Inc. | 02/16/2024SE |
| K231475 | MONTAGE-QS Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 10/12/2023SE |
| K221933 | MONTAGE Settable, Resorbable Bone PuttyGXP · Traditional | Orthocon, Inc. | 01/13/2023SE |
| K182742 | Db-CmfGXP · Traditional | Dimensional Bioceramics, LLC | 06/20/2019SE |
| K162864 | OsteoVation ImpactGXP · Traditional | Skeletal Kinetics, LLC | 01/13/2017SE |
More from Skeletal Kinetics, 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 |
| K030554 | CallosMQV · Traditional | 05/20/2003SE |
Questions and answers
When was Callos CMF Bone Void Filler cleared by the FDA?
Callos CMF Bone Void Filler (K042072) received a 510(k) decision of Substantially Equivalent on September 16, 2004, 45 days after the submission was received.
What is the product code of K042072?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.