510(k) K922142
K922142 is an FDA 510(k) premarket notification submitted by Bio-Tech Co. for the device "FX-CABLELOK SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 20, 1992. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Bio-Tech Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 20, 1992
- Date Received
- May 6, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type
- 510(k)