TransLoc 3D
FDA 510(k) clearance K211496 · decided 2022-07-27
Clearance details
- K-number
- K211496
- Device name
- TransLoc 3D
- Applicant
- Foundation Fusion Solutions, LLC (Dba Cornerloc)
- Decision
- Substantially Equivalent
- Date received
- 2021-05-13
- Decision date
- 2022-07-27
- Days to decision
- 440 days
- Clearance type
- Traditional
- Product code
- OUR
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tulsa, OK, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.