FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K Number: K964537
·
Decision Jan 24, 1997
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
43
Applicant Total
4
Review Days
73
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Basic Information
- Device Name
- BONESOURCE HYDROXYAPATITE CEMENT (HAC)
- K Number
- K964537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteogenics, Inc.
- Date Received
- November 12, 1996
- Decision Date
- January 24, 1997
- Product Code
- GXP
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXP | Methyl Methacrylate For Cranioplasty | FDA class 2 | Neurology |
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