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FDA 510(k)

CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD

K-Number: K840955 · 1984-06-19

ApplicantSynthes (Usa)
Decision Date1984-06-19
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K840955. 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 CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD?

CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Synthes (Usa). The 510(k) number is K840955.

When did CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD receive FDA 510(k) clearance?

CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD received FDA 510(k) clearance on 1984-06-19, under 510(k) number K840955.

Who is the listed applicant for CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD?

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 CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD?

The FDA product code for CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD is JEY.

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Other records listing Synthes (Usa) as applicant

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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.

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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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