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FDA 510(k)

ORMCO TRANSMANDIBULAR IMPLANT

K-Number: K852894 · 1985-08-29

ApplicantOrmco Corp.
Decision Date1985-08-29
Product CodeMDL
Advisory CommitteeDE
DecisionUnknown

Device Summary

ORMCO TRANSMANDIBULAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1985-08-29 under 510(k) number K852894. The device is classified under product code MDL. It was reviewed by the DE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ORMCO TRANSMANDIBULAR IMPLANT?

ORMCO TRANSMANDIBULAR IMPLANT is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Ormco Corp.. The 510(k) number is K852894.

When did ORMCO TRANSMANDIBULAR IMPLANT receive FDA 510(k) clearance?

ORMCO TRANSMANDIBULAR IMPLANT received FDA 510(k) clearance on 1985-08-29, under 510(k) number K852894.

Who is the listed applicant for ORMCO TRANSMANDIBULAR IMPLANT?

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

What is the FDA product code for ORMCO TRANSMANDIBULAR IMPLANT?

The FDA product code for ORMCO TRANSMANDIBULAR IMPLANT is MDL.

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Other records listing Ormco Corp. as applicant

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Related Devices (Code: MDL)

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.

K900433SMOOTH STAPLE IMPLANTInterphase Implants, Inc.

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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