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FDA 510(k)

SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM

K-Number: K080331 · 2008-04-30

ApplicantSynthes (Usa)
Decision Date2008-04-30
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-04-30 under 510(k) number K080331. 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 SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM?

SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-30. The listed applicant is Synthes (Usa). The 510(k) number is K080331.

When did SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM receive FDA 510(k) clearance?

SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM received FDA 510(k) clearance on 2008-04-30, under 510(k) number K080331.

Who is the listed applicant for SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM?

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

What is the FDA product code for SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM?

The FDA product code for SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM is JEY.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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