Polybone
FDA 510(k) K070012 · Kyung Won Medical Co., Ltd.
510(k) numberK070012
Submission
- Device name
- Polybone
- Applicant
- Kyung Won Medical Co., Ltd.
Santa Fe Springs, CA, US - Received
- January 3, 2007
- Decision date
- December 27, 2007
- 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 |
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Questions and answers
When was Polybone cleared by the FDA?
Polybone (K070012) received a 510(k) decision of Substantially Equivalent on December 27, 2007, 358 days after the submission was received.
What is the product code of K070012?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.