FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROXYLAPATITE
K Number: K811101
·
Decision Nov 20, 1981
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
22
Review Days
213
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Basic Information
- Device Name
- HYDROXYLAPATITE
- K Number
- K811101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Carbomedics, Inc.
- Date Received
- April 21, 1981
- Decision Date
- November 20, 1981
- 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 Carbomedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970375 | ANNULOFLO SYSTEM | Jul 25, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964665 | VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) | Feb 19, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K962154 | CARBOMEDICS HANDLE | Aug 27, 1996 | Substantially Equivalent |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Apr 29, 1996 | Substantially Equivalent |
| K960706 | VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT | Apr 25, 1996 | Unknown |
| K960169 | CARBOMEDICS VALVE TESTER | Apr 15, 1996 | Substantially Equivalent |
| K955588 | VASCUTEK GRAFT SIZER SET | Mar 7, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K952184 | CARBOMEDICS SUPRA-ANNULAR VALVE SIZER | Nov 29, 1995 | Substantially Equivalent |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Jun 20, 1995 | Substantially Equivalent |
| K942736 | CARBOMEDICS(R) PROSTHETIC HEART VALVE HOLDER HANDLE | Jul 6, 1994 | Substantially Equivalent |