FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
OTI BONE CEMENT PLUG
K Number: K030608
·
Decision Jun 12, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
21
Review Days
106
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Basic Information
- Device Name
- OTI BONE CEMENT PLUG
- K Number
- K030608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Osteoimplant Technology, Inc.
- Date Received
- February 26, 2003
- Decision Date
- June 12, 2003
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Osteoimplant Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | Jan 25, 2005 | Substantially Equivalent |
| K041443 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | Nov 16, 2004 | Substantially Equivalent |
| K040225 | OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM | May 6, 2004 | Substantially Equivalent |
| K032729 | Z-SERIES MODULAR TOTAL HIP SYSTEM | Dec 3, 2003 | Substantially Equivalent |
| K022779 | OTI UNICONDULAR INTERPOSITIONAL SPACER | Nov 20, 2002 | Substantially Equivalent |
| K021822 | R120 MODULAR TOTAL HIP SYSTEM | Jul 23, 2002 | Substantially Equivalent |
| K012762 | MJS POSTERIOR STABILIZED KNEE SYSTEM | Dec 11, 2001 | Substantially Equivalent |
| K011774 | R120 MODULAR TOTAL HIP SYSTEM | Sep 5, 2001 | Substantially Equivalent |
| K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM | Jan 19, 2001 | Substantially Equivalent |
| K003199 | TRIAD II MODULAR TOTAL HIP SYSTEM | Jan 10, 2001 | Substantially Equivalent |