Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Longeviti ClearFit™ OTS Cranial Implants

K-Number: K212058 · 2021-09-08

ApplicantLongeviti Neuro Solutions, LLC
Decision Date2021-09-08
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Longeviti ClearFit™ OTS Cranial Implants is the device name listed in this FDA 510(k) record. The listed applicant is Longeviti Neuro Solutions, LLC. It received FDA 510(k) clearance on 2021-09-08 under 510(k) number K212058. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Longeviti ClearFit™ OTS Cranial Implants?

Longeviti ClearFit™ OTS Cranial Implants is a medical device that received FDA 510(k) clearance on 2021-09-08. The listed applicant is Longeviti Neuro Solutions, LLC. The 510(k) number is K212058.

When did Longeviti ClearFit™ OTS Cranial Implants receive FDA 510(k) clearance?

Longeviti ClearFit™ OTS Cranial Implants received FDA 510(k) clearance on 2021-09-08, under 510(k) number K212058.

Who is the listed applicant for Longeviti ClearFit™ OTS Cranial Implants?

The FDA 510(k) record lists Longeviti Neuro Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Longeviti ClearFit™ OTS Cranial Implants?

The FDA product code for Longeviti ClearFit™ OTS Cranial Implants is GXN.

Other records listing Longeviti Neuro Solutions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)K231920Longeviti ClearFit OTS Cranial ImplantK211514Longeviti PorousFit implantK210616Longeviti PMMA Static Cranial ImplantK203349Longeviti ClearFit Cranial ImplantK202901Longeviti ClearFit Cranial Implant

View all 9 devices →

Related Devices (Code: GXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑