Parallax Cranioset
FDA 510(k) K994022 · Parallax Medical, Inc.
510(k) numberK994022
Submission
- Device name
- Parallax Cranioset
- Applicant
- Parallax Medical, Inc.
Mountain View, CA, US - Received
- November 26, 1999
- Decision date
- August 31, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| 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 |
|---|---|---|
| K033230 | Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special | 12/12/2003SE |
| K023445 | Tracers Bone Cement OpacifierMYU · Special | 03/11/2003SE |
| K022169 | Clearview Plus Bone and Vertebral Body Biopsy NeedlesKNW · Special | 07/25/2002SE |
| K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesKNW · Abbreviated | 07/18/2001SE |
| K991893 | Parallax Tracer Radiopaque ParticlesMYU · Traditional | 08/13/1999SE |
Questions and answers
When was Parallax Cranioset cleared by the FDA?
Parallax Cranioset (K994022) received a 510(k) decision of Substantially Equivalent on August 31, 2000, 279 days after the submission was received.
What is the product code of K994022?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.