510(k) K170278
K170278 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners". The FDA issued a decision of Substantially Equivalent on May 31, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2017
- Date Received
- Jan 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type
- 510(k)