Tracers Ta Bone Cement Opacifier, Model Tcr-Ta
FDA 510(k) K033230 · Parallax Medical, Inc.
510(k) numberK033230
Submission
- Device name
- Tracers Ta Bone Cement Opacifier, Model Tcr-Ta
- Applicant
- Parallax Medical, Inc.
Scotts Valley, CA, US - Received
- October 6, 2003
- Decision date
- December 12, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code MYU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032388 | Bone Cement Radio-OpacifierMYU · Traditional | Cardinalhealth | 10/31/2003SE |
| K024359 | Vista Scientific Barium Sulfate, Model 3001-1MYU · Abbreviated | Vista Scientific, LLC | 08/08/2003SE |
| K023445 | Tracers Bone Cement OpacifierMYU · Special | Parallax Medical, Inc. | 03/11/2003SE |
| K002063 | Biotrace, Model 1730MYU · Traditional | Bryan Corp. | 08/10/2000SE |
| K991893 | Parallax Tracer Radiopaque ParticlesMYU · Traditional | Parallax Medical, Inc. | 08/13/1999SE |
More from Parallax Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K994022 | Parallax CraniosetGXP · Traditional | 08/31/2000SE |
| K991893 | Parallax Tracer Radiopaque ParticlesMYU · Traditional | 08/13/1999SE |
Questions and answers
When was Tracers Ta Bone Cement Opacifier, Model Tcr-Ta cleared by the FDA?
Tracers Ta Bone Cement Opacifier, Model Tcr-Ta (K033230) received a 510(k) decision of Substantially Equivalent on December 12, 2003, 67 days after the submission was received.
What is the product code of K033230?
The FDA product code is MYU – Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.