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FDA 510(k)

DEPUY STTUNE (TM) PS KNEE SYSTEM

K-Number: K111433 · 2011-08-30

ApplicantDePuy Orthopaedics, Inc.
Decision Date2011-08-30
Product CodeOIY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY STTUNE (TM) PS KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2011-08-30 under 510(k) number K111433. 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 DEPUY STTUNE (TM) PS KNEE SYSTEM?

DEPUY STTUNE (TM) PS KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-30. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K111433.

When did DEPUY STTUNE (TM) PS KNEE SYSTEM receive FDA 510(k) clearance?

DEPUY STTUNE (TM) PS KNEE SYSTEM received FDA 510(k) clearance on 2011-08-30, under 510(k) number K111433.

Who is the listed applicant for DEPUY STTUNE (TM) PS KNEE SYSTEM?

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

What is the FDA product code for DEPUY STTUNE (TM) PS KNEE SYSTEM?

The FDA product code for DEPUY STTUNE (TM) PS KNEE SYSTEM is OIY.

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Other records listing DePuy Orthopaedics, Inc. as applicant

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.

K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

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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, LLCK121727MOVATION KNEE SYSTEMEncore Medical L.P.K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PAEncore Medical L.P.

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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