All-Suture Anchor
FDA 510(k) clearance K231078 · decided 2023-10-05
Clearance details
- K-number
- K231078
- Device name
- All-Suture Anchor
- Applicant
- Riverpoint Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-04-17
- Decision date
- 2023-10-05
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.