Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
The Barium Sulfate and Methyl Methacrylate Accessory for Cranioplasty is a neurosurgical material used in cranial repair procedures, where polymethyl methacrylate (PMMA) bone cement is mixed with barium sulfate (a radiopacifier) to allow radiographic visualization of the implanted material. It is used to reconstruct cranial defects following trauma, surgery, or infection. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 882.5300 (Neurology specialty). This device carries the implant flag.
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Basic Information
- Product Code
- MYU
- Device Class
- FDA class 2
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K033230 | TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA | Dec 12, 2003 | Substantially Equivalent | Parallax Medical, Inc. |
| K032388 | BONE CEMENT RADIO-OPACIFIER | Oct 31, 2003 | Substantially Equivalent | Cardinalhealth |
| K024359 | VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 | Aug 08, 2003 | Substantially Equivalent | Vista Scientific, LLC |
| K023445 | TRACERS BONE CEMENT OPACIFIER | Mar 11, 2003 | Substantially Equivalent | Parallax Medical, Inc. |
| K002063 | BIOTRACE, MODEL 1730 | Aug 10, 2000 | Substantially Equivalent | Bryan Corp. |
| K991893 | PARALLAX TRACER RADIOPAQUE PARTICLES | Aug 13, 1999 | Substantially Equivalent | Parallax Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.