510(k) K002125
K002125 is an FDA 510(k) premarket notification submitted by Implant Resource, Inc. for the device "PINS AND WIRES". The FDA issued a decision of Substantially Equivalent on October 11, 2000. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Implant Resource, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2000
- Date Received
- July 14, 2000
- 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