FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K Number: K040225
·
Decision May 6, 2004
Classifications
1
FEI Numbers
156
Registration Numbers
156
Same Product Code
33
Applicant Total
21
Review Days
94
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
- K Number
- K040225
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3310
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteoimplant Technology, Inc.
- Date Received
- February 2, 2004
- Decision Date
- May 6, 2004
- Product Code
- KWZ
- 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 |
|---|---|---|---|
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWZ), ordered by most recent decision date.
Mpact Constrained Liner
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLETM Constrained Acetabular Liners
FDA 510(k)
FDA Class 2
·Orthopedic
Smith & Nephew, Inc. R3 Constrained Liner
FDA 510(k)
FDA Class 2
·Orthopedic
EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Lateral Offset Proximal Body Implant, EXPRT Hip Capture Bolt
FDA 510(k)
FDA Class 2
·Orthopedic
EXPRT Revision Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
SMITH & NEPHEW R3 CONSTRAINED LINERS
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| 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 |
| K003316 | OTI CERAMIC FEMORAL HEAD SYSTEM | Jan 19, 2001 | Substantially Equivalent |
| K003199 | TRIAD II MODULAR TOTAL HIP SYSTEM | Jan 10, 2001 | Substantially Equivalent |