OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
FDA 510(k) clearance K191287 · decided 2019-07-16
Clearance details
- K-number
- K191287
- Device name
- OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
- Applicant
- Davol Inc., Subsidiary of C.R. Bard
- Decision
- Substantially Equivalent
- Date received
- 2019-05-13
- Decision date
- 2019-07-16
- Days to decision
- 64 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warwick, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.