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FDA 510(k)

MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU

K-Number: K860133 · 1986-03-10

ApplicantDepuy, Inc.
Decision Date1986-03-10
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1986-03-10 under 510(k) number K860133. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU?

MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU is a medical device that received FDA 510(k) clearance on 1986-03-10. The listed applicant is Depuy, Inc.. The 510(k) number is K860133.

When did MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU receive FDA 510(k) clearance?

MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU received FDA 510(k) clearance on 1986-03-10, under 510(k) number K860133.

Who is the listed applicant for MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU?

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

What is the FDA product code for MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU?

The FDA product code for MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU is HRY.

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Other records listing Depuy, Inc. as applicant

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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