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FDA 510(k)

S.T.E.P. UNI-KNEE

K-Number: K940389 · 1995-01-19

ApplicantS.T.E.P. Orthopaedics, Inc.
Decision Date1995-01-19
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

S.T.E.P. UNI-KNEE is the device name listed in this FDA 510(k) record. The listed applicant is S.T.E.P. Orthopaedics, Inc.. It received FDA 510(k) clearance on 1995-01-19 under 510(k) number K940389. 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 S.T.E.P. UNI-KNEE?

S.T.E.P. UNI-KNEE is a medical device that received FDA 510(k) clearance on 1995-01-19. The listed applicant is S.T.E.P. Orthopaedics, Inc.. The 510(k) number is K940389.

When did S.T.E.P. UNI-KNEE receive FDA 510(k) clearance?

S.T.E.P. UNI-KNEE received FDA 510(k) clearance on 1995-01-19, under 510(k) number K940389.

Who is the listed applicant for S.T.E.P. UNI-KNEE?

The FDA 510(k) record lists S.T.E.P. Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.T.E.P. UNI-KNEE?

The FDA product code for S.T.E.P. UNI-KNEE is HRY.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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