Bonesource Hydroxyapatite Cement (Hac)
FDA 510(k) K953339 · Osteogenics, Inc.
510(k) numberK953339
Submission
- Device name
- Bonesource Hydroxyapatite Cement (Hac)
- Applicant
- Osteogenics, Inc.
Richardson, TX, US - Received
- July 17, 1995
- Decision date
- June 27, 1996
- 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 |
|---|---|---|
| K061934 | XtacFTL · Traditional | 07/17/2007SE |
| K983753 | Star Temporary Wound CoverFTL · Traditional | 11/18/1999SE |
| K972278 | Cytoplast Regentex Titanium 250LYC · Traditional | 08/06/1997SE |
| K964342 | Cytoplast GBRLYC · Traditional | 03/11/1997SE |
| K964537 | Bonesource Hydroxyapatite Cement (Hac)GXP · Traditional | 01/24/1997SE |
Questions and answers
When was Bonesource Hydroxyapatite Cement (Hac) cleared by the FDA?
Bonesource Hydroxyapatite Cement (Hac) (K953339) received a 510(k) decision of Substantially Equivalent on June 27, 1996, 346 days after the submission was received.
What is the product code of K953339?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.