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FDA 510(k)

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT

K-Number: K111970 · 2012-02-23

ApplicantTornier
Decision Date2012-02-23
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Tornier. It received FDA 510(k) clearance on 2012-02-23 under 510(k) number K111970. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT?

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT is a medical device that received FDA 510(k) clearance on 2012-02-23. The listed applicant is Tornier. The 510(k) number is K111970.

When did KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT receive FDA 510(k) clearance?

KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT received FDA 510(k) clearance on 2012-02-23, under 510(k) number K111970.

Who is the listed applicant for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT?

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

What is the FDA product code for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT?

The FDA product code for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT is KRR.

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Other records listing Tornier 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.

K112144AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESISK111902AEQUALIS SHOULDER SYSTEMK094013HLS KNEETEC SYSTEMK100142AEQUALIS REVERSED SHOULDER PROSTHESISK091870TORNIER, PITON FIXATION IMPLANT SYSTEMK090076SALTO TALARIS TOTAL ANKLE PROSTHESIS

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Related Devices (Code: KRR)

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.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, 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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