FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FX-CABLELOK SYSTEM
K Number: K922142
·
Decision Nov 20, 1992
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
128
Applicant Total
2
Review Days
198
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Basic Information
- Device Name
- FX-CABLELOK SYSTEM
- K Number
- K922142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio-Tech Co.
- Date Received
- May 6, 1992
- Decision Date
- November 20, 1992
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Bio-Tech Co.
| K Number | Device Name | ||
|---|---|---|---|
| K900674 | CONSTI-SSAGE VIBRATOR/MASSAGE | Mar 2, 1990 | Substantially Equivalent |