FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
REPLICA(TM) TOTAL HIP SYSTEM
K Number: K926156
·
Decision Mar 9, 1994
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
560
Applicant Total
18
Review Days
457
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Basic Information
- Device Name
- REPLICA(TM) TOTAL HIP SYSTEM
- K Number
- K926156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3358
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Osteo Technology, Inc.
- Date Received
- December 7, 1992
- Decision Date
- March 9, 1994
- Product Code
- LPH
- 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Osteo Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | Sep 23, 1993 | Substantially Equivalent |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | Jul 13, 1993 | Substantially Equivalent |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | Jun 29, 1993 | Substantially Equivalent |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | Jun 17, 1993 | Substantially Equivalent |
| K922861 | BIOMETRIC SCREW FIXATION CUP | May 12, 1993 | Substantially Equivalent |
| K922870 | THREE SPIKE CUP | Apr 8, 1993 | Substantially Equivalent |
| K922682 | AMERICANA HIP PROTHESIS | Mar 16, 1993 | Substantially Equivalent |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | Mar 16, 1993 | Substantially Equivalent |
| K922871 | UNIFIT FEMORAL STEM | Feb 12, 1993 | Substantially Equivalent |
| K922868 | THOMPSON TYPE HIP PROTHESIS | Feb 12, 1993 | Substantially Equivalent |