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FDA 510(k)

CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM

K-Number: K951691 · 1995-07-26

ApplicantMedicon EG
Decision Date1995-07-26
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 1995-07-26 under 510(k) number K951691. 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 CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM?

CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-26. The listed applicant is Medicon EG. The 510(k) number is K951691.

When did CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM receive FDA 510(k) clearance?

CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM received FDA 510(k) clearance on 1995-07-26, under 510(k) number K951691.

Who is the listed applicant for CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM?

The FDA 510(k) record lists Medicon EG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM?

The FDA product code for CMS CRANIO MAXILLO FACIAL TITANIUM IMPLANT SYSTEM is JEY.

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Other records listing Medicon EG 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.

K161680MEDICON Spinal Spreading SystemsK100916MEDICON MOGEN CLAMPK083803FIXIT HEADREST CLAMP SYSTEMK053624MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEMK050478MEDICON IMF-ORION SCREWSK043297MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM

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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

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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