X-Twist PEEK Suture Anchor
FDA 510(k) clearance K221135 · decided 2022-05-19
Clearance details
- K-number
- K221135
- Device name
- X-Twist PEEK Suture Anchor
- Applicant
- Parcus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-04-19
- Decision date
- 2022-05-19
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.