510(k) K970084
K970084 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "LINK CERCLAGE WIRE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 1997. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1997
- Date Received
- January 9, 1997
- 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