FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTI CERAMIC FEMORAL HEAD SYSTEM
K Number: K003316
·
Decision Jan 19, 2001
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
21
Review Days
88
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Basic Information
- Device Name
- OTI CERAMIC FEMORAL HEAD SYSTEM
- K Number
- K003316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteoimplant Technology, Inc.
- Date Received
- October 23, 2000
- Decision Date
- January 19, 2001
- Product Code
- LZO
- Advisory Committee
- Orthopedic
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
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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 |
| K030608 | OTI BONE CEMENT PLUG | Jun 12, 2003 | Unknown |
| 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 |
| K003199 | TRIAD II MODULAR TOTAL HIP SYSTEM | Jan 10, 2001 | Substantially Equivalent |