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FDA 510(k)

METICULY Patient-specific titanium maxillofacial mesh implant

K-Number: K232889 · 2024-04-30

ApplicantMeticuly Co., Ltd.
Decision Date2024-04-30
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

METICULY Patient-specific titanium maxillofacial mesh implant is the device name listed in this FDA 510(k) record. The listed applicant is Meticuly Co., Ltd.. It received FDA 510(k) clearance on 2024-04-30 under 510(k) number K232889. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METICULY Patient-specific titanium maxillofacial mesh implant?

METICULY Patient-specific titanium maxillofacial mesh implant is a medical device that received FDA 510(k) clearance on 2024-04-30. The listed applicant is Meticuly Co., Ltd.. The 510(k) number is K232889.

When did METICULY Patient-specific titanium maxillofacial mesh implant receive FDA 510(k) clearance?

METICULY Patient-specific titanium maxillofacial mesh implant received FDA 510(k) clearance on 2024-04-30, under 510(k) number K232889.

Who is the listed applicant for METICULY Patient-specific titanium maxillofacial mesh implant?

The FDA 510(k) record lists Meticuly Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant?

The FDA product code for METICULY Patient-specific titanium maxillofacial mesh implant is JEY.

Related Clinical Trials

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.

NCT07212855Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge ProtocolCOMPLETEDNCT076510333D Titanium Plates for Mandibular Parasymphyseal Fracture FixationCOMPLETEDNCT076510593D Titanium Plates for Mandibular Body Fracture FixationCOMPLETEDNCT07698678Evaluation of Using Patient Specific Ultra-High Molecular Weight Polyethylene Implant Versus Patient Specific Titanium Implant in Treatment of Chronic Condylar Dislocation A Randomized Control TrialACTIVE_NOT_RECRUITINGNCT07520903Titanium-Reinforced PTFE Membranes for Bone AugmentationCOMPLETED

Other records listing Meticuly Co., Ltd. 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.

K253206METICULY Patient-specific CMF solutionK252958METICULY Patient-specific titanium mesh implantK210099Meticuly Patient-Specific Titanium Mesh Implant

Related Devices (Code: JEY)

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.

K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.K240651MRI UniversalStryker Leibinger GmbH & Co KG

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.

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