510(k) K874676
K874676 is an FDA 510(k) premarket notification submitted by Concept, Inc. for the device "INTERFERENCE SCREW". The FDA issued a decision of Substantially Equivalent on March 7, 1988. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Concept, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 7, 1988
- Date Received
- November 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type