Longeviti ClearFit™ OTS Cranial Implants
FDA 510(k) clearance K212058 · decided 2021-09-08
Clearance details
- K-number
- K212058
- Device name
- Longeviti ClearFit™ OTS Cranial Implants
- Applicant
- Longeviti Neuro Solutions, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-07-01
- Decision date
- 2021-09-08
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- GXN
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Hunt Valley, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.