FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
K Number: K926213
·
Decision Jun 17, 1993
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
18
Review Days
189
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Basic Information
- Device Name
- MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM
- K Number
- K926213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Osteo Technology, Inc.
- Date Received
- December 10, 1992
- Decision Date
- June 17, 1993
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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Other Clearances by Osteo Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | Mar 9, 1994 | Substantially Equivalent for Some Indications |
| 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 |
| 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 |