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FDA 510(k)

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE

K-Number: K102641 · 2010-12-20

ApplicantNeoortho Produtos Ortopedicos S/A
Decision Date2010-12-20
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopedicos S/A. It received FDA 510(k) clearance on 2010-12-20 under 510(k) number K102641. 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 MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE?

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE is a medical device that received FDA 510(k) clearance on 2010-12-20. The listed applicant is Neoortho Produtos Ortopedicos S/A. The 510(k) number is K102641.

When did MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE receive FDA 510(k) clearance?

MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE received FDA 510(k) clearance on 2010-12-20, under 510(k) number K102641.

Who is the listed applicant for MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE?

The FDA 510(k) record lists Neoortho Produtos Ortopedicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE?

The FDA product code for MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE is JEY.

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Other records listing Neoortho Produtos Ortopedicos S/A 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.

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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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.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.

Official Source

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