510(k) K191287
K191287 is an FDA 510(k) premarket notification submitted by Davol Inc., Subsidiary of C.R. Bard 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 July 16, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2019
- Date Received
- May 13, 2019
- Clearance Type
- Special
- 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