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FDA 510(k)

MOVATION KNEE SYSTEM

K-Number: K121727 · 2012-08-15

ApplicantEncore Medical L.P.
Decision Date2012-08-15
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MOVATION KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Encore Medical L.P.. It received FDA 510(k) clearance on 2012-08-15 under 510(k) number K121727. The device is classified under product code OIY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOVATION KNEE SYSTEM?

MOVATION KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2012-08-15. The listed applicant is Encore Medical L.P.. The 510(k) number is K121727.

When did MOVATION KNEE SYSTEM receive FDA 510(k) clearance?

MOVATION KNEE SYSTEM received FDA 510(k) clearance on 2012-08-15, under 510(k) number K121727.

Who is the listed applicant for MOVATION KNEE SYSTEM?

The FDA 510(k) record lists Encore Medical L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOVATION KNEE SYSTEM?

The FDA product code for MOVATION KNEE SYSTEM is OIY.

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Related Devices (Code: OIY)

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.

K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.K120038A200 KNEE SYSTEMRenovis Surgical Technologies, LLCK113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.K111433DEPUY STTUNE (TM) PS KNEE SYSTEMDePuy Orthopaedics, 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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