510(k) K971453
K971453 is an FDA 510(k) premarket notification submitted by Orthotech for the device "ORTHOTEC K-CAP SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Orthotech has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1997
- Date Received
- April 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type