FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROXYAPATITE
K Number: K842718
·
Decision Nov 7, 1984
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
303
Review Days
117
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Basic Information
- Device Name
- HYDROXYAPATITE
- K Number
- K842718
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Depuy, Inc.
- Date Received
- July 13, 1984
- Decision Date
- November 7, 1984
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
Similar 510(k) Clearances
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FG Bone Graft B
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Synthetic Bone Graft Particulate
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CMFlexTM
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|---|---|---|---|
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| K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS | Sep 26, 2003 | Substantially Equivalent |
| K020541 | AGILITY ANKLE REVISION PROSTHESIS | May 20, 2002 | Substantially Equivalent |
| K011810 | ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING | Sep 7, 2001 | Substantially Equivalent |