Methyl Methacrylate For Aneurysmorrhaphy
Methyl Methacrylate for Aneurysmorrhaphy is a surgical implant material composed of methyl methacrylate bone cement used to reconstruct or reinforce cranial defects or repair intracranial aneurysms during neurosurgical procedures. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is JXH, regulated under 21 CFR 882.5030, and falls within the Neurology medical specialty. This device is an implant.
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Basic Information
- Product Code
- JXH
- Device Class
- FDA class 2
- Regulation Number
- 882.5030
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071776 | ANEUROPLASTIC, MODEL 43-1290 | Jul 26, 2007 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K882072 | ORTHOPAEDIC AND SPINAL RING CURRETTES | Jun 17, 1988 | Substantially Equivalent | Karlin Technology, Inc. |
| K873688 | ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL | Oct 26, 1987 | Substantially Equivalent | Dentsply Intl. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.