FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HA-2000 HYDROXYLAPATITE
K Number: K852765
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
8
Review Days
87
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Basic Information
- Device Name
- HA-2000 HYDROXYLAPATITE
- K Number
- K852765
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Orthomatrix, Inc.
- Date Received
- June 28, 1985
- Decision Date
- September 23, 1985
- 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 |
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Other Clearances by Orthomatrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010738 | CANNULATED PLUS SCREW SYSTEM | Aug 1, 2001 | Substantially Equivalent |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | Dec 13, 2000 | Substantially Equivalent |
| K992856 | MAGELLAN HUMERAL INTRAMEDULLARY NAIL | Mar 10, 2000 | Substantially Equivalent |
| K992850 | MAGELLAN TIBIAL INTRAMEDULLARY NAIL | Mar 10, 2000 | Substantially Equivalent |
| K852766 | HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI | Oct 21, 1985 | Substantially Equivalent |
| K851367 | HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION | May 21, 1985 | Substantially Equivalent |
| K842163 | RIDGEMATRIX 20/40 MESH, PERIOMATRIX | Aug 9, 1984 | Substantially Equivalent |