510(k) K170782
K170782 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline UNITE® Snap-Off Screws". The FDA issued a decision of Substantially Equivalent on Aug 18, 2017. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 2017
- Date Received
- Mar 15, 2017
- Clearance Type
- Special
- 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
- 510(k)